Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.

इंटरनेट मानक

“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda

“Invent a New India Using Knowledge”

“प0रा1 को छोड न' 5 तरफ”Jawaharlal Nehru

“Step Out From the Old to the New”

“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan

“The Right to Information, The Right to Live”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam

“Knowledge is such a treasure which cannot be stolen”

“Invent a New India Using Knowledge”

है”ह”ह

IS 9824-3 (1996): Transfusion equipment for medical use,Part 3: Transfusion sets for single use [MHD 13: VeterinaryHospital Planning and Surgical Instruments]

IS9824(Part3):1996

*m

TRANSFUSION EQUIPMENT FORMEDICAL USE - SPECIFICATION

PART 3 TRANSFUSION SET FOR SINGLE USE

( First Revision )

ICS 1 l.WO.20

0 BIS 1996

B U R E A U O F I N D I A N S T A N D A R D SMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

Murch 1996 Price Group 4

Anaesthetic, Resuscitation and Allied Equipment Sectional Committee, MHD 13

FOREWORD

This Indian Standard (Part 3) (First Revision) was adopted by the Bureau of Indian Standards, after thedraft finalized by the Anaesthetic, Resuscitation and Allied Equipment Sectional Committee had beenapproved by the Medical Equipment and Hospital Planning Division Council.

This standard was first issued in 1981 and covered the requirements for disposable and reusable typetransfusion equipment in line with IS0 11351977 ‘Transfusion equipment for medical use’ published bythe International Organization for Standardization. IS0 1135 has since been revised and issued infollowing three parts:

IS0 1135-1 : 1987 Transfusion equipment for medical use - Part 1 : Glass transfusion bottles,closures and caps

IS0 1135-3 : 1986 Transfusion equipment for medical use - Part 3 : Blood-taking set

IS0 1135-4 : 1987 Transfusion equipment for medical use - Part 4 : Transfusion sets for single use

Accordingly the Committee decided to revise this standard aligning it with the practices being followedat the international level and issue it in three parts. This standard (Part 3) covers the requirements forsterile transfusion sets for single use, whereas the other two parts cover the following :

Transfusion equipment for medical use - Part 1 : Glass transfusion bottles, closures and caps.

Transfusion equipment for medical use - Part 2 : Blood-taking sets for single use

The major changes effected through this revision include the following :

a) Reusable type transfusion sets have been excluded as they are no longer being used in thecountry.

b) Tests such as sterility, pyrogens and systemic toxicity have been included as laid down in IndianPharmacopoeia, whereas the guidelines and procedures for assessment of Hemolysis and otherbiological tests have been specified in accordance with the relevant parts of IS 12572 ‘Biologicalevaluation of medical devices’.

Transfusion sets for single USC (which form a part of Perfusion sets for single use) have been declared as‘Drug’ under the Drugs and Cosmetic Rules, 1945 by the Drugs Controller of India and their conformitywith this Indian Standard has been made mandatory. Accordingly, the regulatory functions.for ensuringconformity to this standard rest with the Drugs Controller of India. Therefore BIS Certification Markingwould not be applicable to these devices.

For the purpose of deciding whether a particular requirement of this standard is complied with, the finalvalue, observed or calculated, expressing the results of a test or analysis, shall be rounded off in accordancewith IS 2 : 1960 ‘Rules for rounding off numerical values (revised)‘. The number of significant placesretained in the rounded off value should be the same as that of the specified value in the standard.

Indian Standard

IS 9824 ( Part 3 ) : 1996

TRANSFUSION EQUIPMENT FORMEDICAL USE - SPECIFICATION

PART 3 TRANSFUSION SET FOR SINGLE USE

( First Revision )1 SCOPE

This Indian Standard (Part 3) specifies require-ments for sterile transfusion sets intended for singleuse and for single patient only in order to ensurecompatibility of use with containers for blood andblood components and intravenous catheters andcannulas.

2 REFERENCES

2.1 The following standards contain provisionswhich through reference in this text, constitulcprovision of this standard. At the time of publica-tion, the editions indicated were valid. All stand-ards are subject to revision, and parties toagreements based on this standard are encouragedto investigate the possibility of applying the mostrecent editions of the standards indicated b&w:

IS No.1070 : 1992

1381 (Part 2) :1977

3234 (Part 1) :1986

3234 (Part 2) :1995

101.50 : 1981

10654 : 1991

12572 (Part 1) :1994

12572 (Part 3) :1988

Tirle

Boiling flasks: Part 2 Flnskswilhconical ground socket (/+.vWi.SiOlZ)Conical fittings with a 6 percent(LUER) taper for syringes, necd-les and certain other medicalequipment: Part 1 General rc-quirements (fi~sf ~Ysio/z)Conical fittings with a 6 percent(LLJER) taper for syringes, need-les and certain other medicalequipment : Part 2 Lock fittingsGuide for sterilization of mcdi-cal productsSterile hypodermic necdlcs forsingle use (second revision)

Biological evaluation of medicaldevices : Part 1 Guidance onselection of tests (li’lsl ~e~isio/z)Guide for evaluation of medicaldevices for biological hazards :

12572 (Par19%

12572 (Par19ss

tj)

t 7)

12572 (Part 14) :1994

Part 3 Method of testing by tis-sue implantationGuide for evaluation of medicaldevices for biological hazards :Part 5 Method of test for in-tracutaneous reactivity of ex-tracts from medical devicesGuide for evaluation of medicaldevices for biological hazards :Part 7 Method of test for sen-sitization : Assessment of thepotential of medical devices toproduce delayed contactdermatitisBiological evaluation of medicaldevices : Part 14 Selection oftests for interactions with blood

3.1 The materials from which the transfusion setis made shall not have undesirable effecrs on theblood passing through the set under ordinary con-ditions of’ USC, or on the lluids used in connectionwith lhe blood. They shall not product any gcncraltoxic eff’ccts or any local reaction on Ihc rccipicntof the blood.

Appropriate type tests for assessing biological com-patibility are given in Annex C.

4.1 Components for Use with Rlood Containers

The transfusion set shall consist of the componcn tsas shown in Fig. 1. An air-inlet dcvicc as shown inFig. 2 shall be used with rigid containers.

NOTE -Figures 1 and 2 illustrate examples of configtm-tions of typical transf~ision sets but they do not form pal-t ofthe reqtkements for transfusion sets tar single use iIs hiddown in this standard.

4.2 Sterilization

The set shall be sterile in its unit container.Documentary evidence of the effectiveness of thesterilization process used shall be provided with

IS 9824 ( Part 3 ) : 1996

1)2)3)4)5)6)7)8)9)

10)11)

Protective cap of the closure-piercing device

Closure-piercing device

Fluid channelFilter for blood and blood components’)Drip tube (counter)Drip chamber

TubingFlow regulatorInjection site’)Male fittingProfective cap of the male fitting

F I G. 1 E~~PLE OF A TY P I C A L

TRANSRJSION SET

each batch of transfusion set. Only ionizing radia-tion or ET0 sterilization method shall be adoptedto sterilize the product (see IS 10150 : 1991).

4.3 Maintenance of Sterility

The set shall be provided with protective capsdesigned to maintain sterility of the internal sur-faces of the set until the set is used.

4.4 Designation Examples

4.4.1 Trmzsfiuion Set

A transfusion set (TS) complying with the require-ments laid down in this standard shall be designatedas:

Tmzg%sion set IS CKY-3 TS

1) Other designs are acceptable if the safety aspects areguaranted.

2) Optional.

1) Protective cap2) Closure-piercing device or needle

3) Tubing4) Clamp”

5) Air filter

F I G. 2 EXMPLE OF A TYPICAL AIR-INLET

DEVICE

4.4.2 Air-inlet Device

An air-inlet device (AD) complying with the re-quiremcnts laid down in this standard shall bedesignated as:

Air-inlet IS 98243 AD

5 I’IIYSICAL REQUIREMENTS

5.1 Integrity

The sterilized transfusion set with one end blocked,shall not leak under an internal air pressure of100 kPa (1 bar) above the atmospheric air pressurewhen immersed in water at 20” to 30°C for 2minutes.

5.2 Connection Between the Male Fitting, Injec-tion Site and Tubing

The connection between the male fitting, injectionsite and the tubing shall withstand a static tensileforce of 15 N for 15 s.

5.3 Closure-Piercing Device

The closure-piercing device to be used for plasticbags shall conform with the dimensions shown inFig. 3.

.

2

All dimensions in millimetres.

F1c.3 DIMENSIONSFORTIHECLOSUREPIERCING DEVICE

5.4 Air-inlet Device

5.4.1 The air-inlet device may be provided with afilter designed to prevent the ingress of micro-or-ganisms into the container into which the device isto be inserted.

5.4.2 The air-inlet device shall be separate fromthe closure-piercing device.

5.4.3 When an air-inlet device is inserted into arigid transfusion container, the air admitted intothe container shall not become entrained in theliquid outflow.

5.4.4 If the end of the air-inlet device is connectedto an air filter by means of flexible tubing, thetubing shall have an internal diameter not less than2.7 mm and shall be not less than 250 mm in length.

5.4.5 If the air-inlet device incorporates a length offlexible tubing, means for fixing the filter above thelevel of the fluid shall be provided.

5.4.6 The air-inlet needle for air-inlet device to beused for glass transfusion bottle only shall be of 25mm min piercing length and lumen dia of 1.3 mmmin.

5.5 Air Filter

The air filter shall be so made that all air enteringthe bottle passes through it and that the flow offluid is not significantly reduced.

5.6 Tubing

5.6.1 The tubing, made of suitable material, shallbe transparent or sufficiently translucent for thepassage of bubbles of air to be readily detected.

5.6.2 The tubing shall have an internal diameter ofnot less than 2.7 mm. The overall length of tubingmeasured from base of closure piercing device (seenomenclature 2 of Fig. 1) to the distal end of thetube shall be not less than 1500 mm in length. Thetubing shall be flexible and shall not have any kinks.

IS 9824 ( Part 3 ) : 1996

5.7 Filter for Blood and Blood Derivates

The transfusion set shall be provided with a filter.The filter shall have uniform apertures covering atotal area of not less than 10 cm’. When tested inaccordance with Annex A, the dry residue retainedon the filter shall be not less than 80 percent (m/m)of the residue retained on the reference filter.

5.8 Drip Chamber and Drip Tube

The drip chamber shall assist the procedure ofpriming and permit continuous observation of thefall of drops. The liquid shall enter the drip cham-ber through a tubewhich projects into the chamber.There shall be a distance of not less than 40 mmbetween the end of the drip tube and the outlet ofthe chamber or a distance of not less than 20 mmbetween the drip tube and filter. The wall of the dripchamber shall not be closer than 5 mm to the endof the drip tube. The drip tube shall bc such that 20drops of distilled water at 20°C and at a flow rate of50 2 5 drops/min deliver 1 + 0.1 ml (1 & 0.1 g).

5.9 Now Regulator

5.9.1 The [low regulator shall adjust the flow of thetransfusion fluid between zero and the maximum.

5.9.2 The flow regulator shall be capable of con-tinuous use throughout a transfusion withoutdamaging the tubing. There shall be no deleteriousreaction between the flow regulator and the tubingwhen stored in contact.

5.10 Flow Kate of Blood

The complete transfusion set shall deliver not lessthan 1 000 ml of whole blood in 30 min under astatic head of 1 m. The blood shall have beencollected into a suitable anticoagulant solution, bestored for not less than 2 weeks and be free of largeclots.

The set shall also deliver 500 ml of blood in 2 minunder a pressure of 100 kPa (1 bar) above theatmospheric pressure.

5.11 Injection Site

There shall be a self-sealing injection port or otherequivalent means near the distal end. Self-sealinginjection ports shall reseal under normal workingpressure after being perforated by a needle 0.6 mmin diameter.

NOTE- The injection rite should be located near the malefitting.

When tested in accordance with 5.11.1, there shallbe no signs of air leakage.

3

1S 9824 ( Part 3 ) : 1996

5.11.1 Perforate the injeclion site at the intendedpoint by means of a needle having an outisdediameter of 0.6 mm. Keep the ncedlc in positionfor 1.5 s. After the needle has been removed, test theinjection site in water under a pressure of 20 kPa(200 mbar) above the atmospheric air pressure for15 s.

5.12 Male Fittitq

The distal end of the tubing shall terminate in amale fitling having a cone with a 6 percent taperconforming with IS 3234 (Part 1) : 1986 or IS 3234(Part 2) : 1995.

When tested in accordance with IS 3234 (Part 1) :1986 or IS 3234 (Part 2) : 1995 using a femalereference fitting, there shall be no signs of airleakage.

5.13 Protective Caps

The protective caps at the end of the transfusion setshall maintain the sterility of the closure-piercingdevice, the male fitting and the interior of the trans-fusion set. They shall be secure but easily remov-abie.

6 CIIEMICAL REQUIREMENTS

6.1 Reducing (Oxidizable) Matter

When tested in accordance with B-2, the totalamount potassium permanganate solution, C(KMnOJ) = 0.002 mol/l used shall not exceed 2.0ml.

6.2 Metal Ions

The extract shall not contain in total more than 1/(g/ml (1 ppm) of barium, chromium, copper, leadand tin, and not more than 0.1 /dg/l (0.1 ppm) ofcadmium, when determined by atomic absorptionspectroscopy (AAS) or equivalent method.

When tested in accordance with B-3, the colourproduced in the test solution shall not exceed thatof the standard matching solution containing p(Pb”+) = I !cg.ml.

6.3 Titration Acidity or Alkalinity

When tested in accordance with IL!, not more than1 ml of either standard volumetric solution shall berequired for the indicator to change to the colourgrey.

6.4 Residue on Evaporation

When tested in accordance with B-5, the totalamount of dry residue shall not exceed 5 mg.

4

6.5 Absorbance

When tested in accordance with B-6, the extractsolution Sl shall not show absorbance greater than0.1 (optical density).

7 BIOLOGICAL REQUIREMEN’I’S

7.1 The transfusion set shall not release any sub-stances which may adversely affect the therapeuticcffcct ivcness of theblood or the blood components,including those substances which may exhibit toxic,pyrogcnic, bacteriostatic, bactericidal orhaemolytic reactions. IS 12572 (Part 1) : 1994 maybe referred to for general guidance on selection oftests.

7.2 Requirements for Type Test

The type test shall be established and assessed byan expert (or experts) in the transfusion field andon toxicolo&y of plastics material. It shall cover thefollowing elements:

a>

b)

C>

4

General biocompatibility of the plasticsmaterial of the set.Materials shall be assessed for biocom-patibility by carrying out suitable tests forthe properties given in C-2 and the resultsof the tests shall indicate freedom fromtoxicity.Compatibility of the rransfusion set with theprocess of manufacture and sterilization.The process of manufacture and sreriliza-tion, and the prolonged contact wirh theblood or blood components shall not alterproperties of the plastics material and of theset itself.Compatibility of the plastics material of theset with blood and blood components.Absence of migration after sterilization andprolonged contact of the constituents of theplastics material shall not alter the proper-ties of the blood or blood components orcause any toxicological risk for the patient.Biocompatibility of the plastics set with thecellular elements of the blood or blood com-ponents.

7.3 Requirements for Acceptance Test

7.3.1 SterilityThe transfusion set shall be assessed for sterility inaccordance with the procedure given in IndianPharmacopoeia and the results shall indicate thatthe transfusion set is sterile.

7.3.2 Pyrogcns

Select ten assemblies representative of the produc-tion of each working day and through the tubing ofeach, pass a separate 40 ml portion of sterile,

pyrogen-Sree snline sohrion conta ining 9 g/lSodium Chloride at a flow rate ofapproximately 10ml per minute. The pooled effluent shall meet therequirements of the test for pyrogcns given in In-dian Pharmacopoeia, the test dose being 10 ml perkg of body weight.

7.3.3 Systemic Tosicit?

Select one assembly representative of the produc-tion of each working day. Fill the assembly as com-pletely as practicable with sterile saline solzitioncontainin!: 9 g/l Sodium Chloride, clamp the endssecurely to retain the solution and immerse thefilled assembly completely in water. Heat thcwaterat not less than S5”C for one hour. Drain the con-tents of the assembly, and dilute with sterile sali~sohtiou to 250 ml. Inject intravenously 0.5 ml ofthis solution into each of five healthy mice weighingbetween 17 and 22 g; at the end of four, twenty-fourand forty-eight hours the animals show no discern-iblc signs of toxicity. If any of the animals showsgoss signs of toxicity or dies, repeat the test withanother five healthy mice weighing between 19 and21 g; all the animals survive for forty-eight hours.

8 MARKING AND LABELLING

8.1 Unit Container

The unit container of each transfusion set for singleUSC shall bc marked with the following information:

a de.scription of the contents, in wordsand/or pictorially;indications that the transfusion set is sterile,free from pyrogcns and for single USC only;instructions for the use of the transfusionset, includinsa warningnoteabout checkingthat seals are intact and about detachedprotective caps;the nominal dimension of an intravenousneedle, if included;the year and month of sterilization, whereapplicable, and the date of expiry, whereapplicable and mode of sterilization;the batch number;the manufacturer’s and/or supplier’s nameand address;a atatemcnt that 20 hrops of distilled waterdelivered by the drip tube are equivalent to1 +- 0.1 ml (1 * 0.1 2);a statement to the effect that the transfusionset shall be dcstroycd after use;the recommended storage conditions, if any;and

IS 9824 ( Part 3 ) : 1996

m) a statement to the effect that air-outlet as-sembly is provided with a microbial ingresspreventing filter, where so provided.

8.2 Shelf or Multi-Unit Container

Shelf or multi-unit containers shall be marked withthe following information:

a>b)C>

4

a description of the contents, in wordsand/or pictorially;the number of transfusion sets;instructions for use in each shelf container,or on the unit container;the word “STERILE” in prominent lettering(see Note in 9.1);

NOTE - This may form part of the description listedunder (a) above.

the manufacturer’s or supplier’s name;the batch number;the year and month of sterilization, whereapplicable, and the date of expiry, whereapplicable; andrhe recommended storage conditions, if any.

8.3 Outer or Transit Container (not Intended tobe the 16nal Shilq)ing Container)

Onteror transit containersshall bemarkedwith thefollowing information:

a)

b)

cld)e)

0

the manufacturer’s or supplier’s name andaddress;a description of the contents, in wordsand/or pictorially;the number of transfusion sets;the lot (batch) number;the year and month of sterilization, whereapplicable, and the date of expiry where ap-plicable; andthe recommended storage conditions, if any.

9 PACKAGING

9.1 The transfusion sets shall bc individuallypacked so that the set remains stcrilc duringstorage.

The unit container shall bc sealed in such a mannerthat it cannot be opened and closed again withoutit being obvious that the container has beenopened.

NUI’E - If. in special cases, only the interior of the set isrequired to be sterile, il slatcmcnt ot this effect should heclearly min-kcd on the shclfor multi-unit container.

9.2 The sets shall be packed and sterilized in sucha way that there are no flattcncd portions or kinkswhen they are ready for use.

IS 9824 ( Part 3 ) : 1996

ANNEX A

( Clause 5.7 )TEST FOR EFFICIENCY OF FILTER

A-l REFERENCE FILTER

Pass a measured volume of prefiltered, storedblood through a test filter and a reference filter andcompare the mass of the material removed by eachfilter.

The reference filter shall be woven in polyamide 66monofilament with a thread diameter of 100 +- 10/cm with a single warp and weft and shall have anaperture size of 200 + 20 pm.

A-2 PROCEDURE

A-2.1 Method I for Filter Material

Cut two circles from the reference filter materialand two circles from the filter material to be tested,each having a diameter of 40 mm. Hold each circleof filter material during the test in a devicesuch thatthe whole surface of each filter material is coveredwith blood throughout the period of the test.

Preparc a 4 1 pool of whole blood with an-ticoagulant of the same AESO group, stored for notless than two weeks, by emptying the packs into alarge vessel through a coarse filter with a mesh 01about 5 mm2. Mix the blood well.

Allow one 800 ml volume ol’the pool to flow undergavity through each circle of filter material. Drainexcess blood from the filter and dry to approximate-ly constant mass in an oven at 60 + 2”Cat a pressureof approximately 0.65 kPa (6.5 mbar).

A-2.2 Method II for Filter Assemblies

The reference filter assembly shall consist of 32 cm’01‘ reference filter material with the bottom endsealed. This shall he contained within a plasticsfilter chamber having an outlet at the bottomformed of a standard drip tube dclivcring 20 dropsper millilitre when distilled water is used. The inlettube shall project into the filter chamber. A suitablerefercncc filter assembly is shown in Fig. 4. The testprocedure shall be followed as described formethod A (see K2.1).

A-3 EXPRESSION OF RESULTS

The mass of solid material, ~~~~~~~ removed by eachcircle of filter material is given by

%m = ml - nt()

wheremo is the mass of the filter before blood hasbeen passed through it; andnzl is the mass of the filter after blood hasbeen passed through it.

-01

(1) Inlet tube (internal diameter)(2) Filter chamber(3) Reference filter

(4) Fit of the filter

(5) Drip tube outlet from filter chamber delivering 20drops/ml

FIG. 4 REFERENCE FILII’EK ASSEMBLY

IS 9824 ( Part 3 ) : 1996

ANNEX B

( Clause 6 )

CHEMICAL TESTS ON TIIE EXTRACT

B - l P R E P A R A T I O N OF E X T R A C T A N DBLANK

The tests shall be carried out on sterilized sets.

Make a closed circulation system from three setsand a 300 ml borosilicate glass boiling flask [see IS1381 (Part 2) : 19771. Fit to the flask a thermostatdevice that maintains the temperature of the liquidin the flask at 37 + 1°C. Circulate 250 ml of purifiedwater for injections, conforming to IS 1070 : 1992,through the system for 2 h at a rate of 1 I/h (e.g.using a peristaltic pump applied to a piece ofsuitable silicone tubing that is as short as possible).Collect all of the solution and allow to cool. This isthe extract solution Sl.

An aliquot of 250 ml of purified water for injectionswhich has been pumped through the closed circula-tion system without the transfusion sets integratedshall be used as the blank solution So.

The extract solution Si and the blank solution Sothus obtained shall be used for the chemical tests.

B-2 TESTS FOR REDUCING (OXII>IZABI,E)MATTER

Add 10 ml of extract solution St, prepared in ac-cordance with B-l, 10 ml of potassium perman-ganate solution, c (KMnO_t) = 0.002 mol/l, and 1ml of sulphuric acid solution, c (H2SOd) = 1 molil,agitate and allow to react for 15 min at roomtemperature.

After 0.1 g of potassium iodide has been added,titrate the solution against a sodium thiosulphatestandard volumetric solution, c (NazS203) = 0.005mol/l, until it goes light brown in colour. Add 5drops of starch solution and continue the,titrationuntil the blue colour has disappeared.

At the same time, carry out a blank test.

Calculate the volume, in millilitres, of 0.002 mol/lpotassium permanganatesolutionconsumed as thedifference between the two titrations.

B-3 Twr F O R M E T A L IONS

Test 10 ml of extract solution St, prepared inaccordance with B-l, for metal ions, using proce-dures endorsed by the Indian pharmacopoeia.Determine the degree of colouration of the extractsolution SI.

B-4 TEST FOR TITRATION ACIDITY ORALKALINITY (BUI‘FERING CAPACITY)

Add 0.1 ml Tashiro indicator solution to 20 ml ofextract solution St in a titration flask.

If the colour of the resulting solution is violet,titrate with sodium hydroxide standard volumetricsolution, c (NaOH) = 0.01 mol/l, and, ifgreen, withhydrochloric acid standard volumetric solution,c (HCL) = 0.01 mol/l, until a greyish colour ap-pears.

Report the result in millilitres of sodium hydroxidesolution or hydrochloric acid solution used.

B-5 TEST FOR NON-VOLATILE RESII)UE

Transfer 50 ml of extract solution St to a taredevaporating dish, and evaporate to dryness at atemperature just below boiling point.

Heat to constant weight at 105’C.

Treat 50 ml of a blank solution So in the samemanner.

Report the result as the difference, in milligrams,between the residual masses obtained from the cx-tract solution St and the blank solution S,.

B-6 TEST FOR ABSORBANCE

Pass the extract solution Sr through a membranefilter (0.45 /drn) to avoid stray light interferences.Within 5 h of preparation. place the solution in ascanning UV spectrometer in a 1 cm quartz cellwith the blank solution 5, in the reference cell andrecord the spectrum in the wavelength range from250 to 320 nm.

Report the result as a recorded diagram showingthe absorbance (extinction) plotted versus thewavelength.

7

1S 9824 ( Part 3 ) : 1996

ANNEXC

( Clar1se 7 )IHOLOGICAL TESTS

C-l I’REPARATION OF TIIE IXI’RAC’I

In aseptic conditions, pass SO ml of a sterilized,pyrogen-free sodium chloride solution (p (N&l) =9 g/l] at a flow rate of approximately 10 ml/minthrough each of five sterilized sets and combine theeffluents.

To prevent secondary contamination, the test li-quids should be used within 30 min afW passingthrough the transfusion sets.

c-2 ‘I-WE TESTS

During type testing, transl’usion sets shall be as-sessed for biological compatibility for the proper-ties given below. The biological test methodsspecified against each of these propcrtics shallserve as a guide (except C-2.7 and C-2.8 which arcmandatory), while assessing the biological com-patibility.

C-2.1 Cytotoxicity - Conforming to IS 22572(Part 12) ‘Biological evaluation of medical dcviccs:Part 12 Test for qtotoxicity invitro methods (U&Uyrcpmim)‘.

C-2.2 Intramuscular Implantation (Short Term)- Conforming to IS 12572 (Part 3) : 1985.

C-2.3 Intrncutaneous Reactivity (Irritation) -Conforming to IS 12572 (Part 5) : 1958.

C-2.4 Sensitization - Conforming to IS 12572(Part 7) : 1988.

C-2.5 IIemolysis - Conforming IS 12572 (Part14) : 1994.

C-2.6 Systemic Toxicity-See 7.3.3.

C-2.7 Pyrogen Test - As per Indian Phar-macopoeia.

C-2.8 Sterility Test - As per Indian Phar-macopoeia.

Ilureau 0fIndi:w St;intl:wtls

BIS is a statutory institution established under the Brrrenrr ofh?d;f~jz Srtl/?d~rrds Acr, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification of goodsand attending to connected matters in the country.

BIS has the copyright of all its publications. No part of these publications may be reproduced in any formwithout the prior permission in writing of BLS. This does not preclude the free use, in the course ofimplementing the standard, of necessary details, such as symbols and sizes, type or grade designations.Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are alsoreviewed periodically; a standard along with amendments is reaffirmed when such review indicates thatno changes arc needed; if the review indicates that changes are needed, it is taken up for revision. Usersof Indian Standards should ascertain that they are in possession of the latest amendments or edition byreferring to the latest issue of ‘BIS Handbook’ and ‘Standards Monthly Additions’.

This Indian Standard has been developed from Dot : No. MHD 13 ( 2301 ).

Amendments Issued She IW~lication

Amend No. Date of Issue Text Affected

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