documento normativo português especificação técnica

DNP TS

DNP TS C0042020007 2020

Documento Normativo Português – Especificação Técnica

ICS 00.000.00

APROVAÇÃO 2020-00-00

CORRESPONDÊNCIA Clique ou toque aqui para introduzir texto.

ELABORAÇÃO CT 4 (CITEVE)

CÓDIGO DE PREÇO X005

EDIÇÃO 2020-00-00

IPQ reprodução proibida

Rua António Gião, 2 2829-513 CAPARICA PORTUGAL

Tel. + 351-212 948 100 Fax + 351-212 948 101 E-mail: [email protected] Internet: www.ipq.pt

Máscara comunitária reutilizável Nível 2 e nível 3 Masque communautaire réutilisable Niveau 2 et niveau 3 Reusable community mask Level 2 and level 3

mailto:[email protected]

http://www.ipq.pt/

Aviso: Documento com direitos de propriedade © IPQ reprodução proibida As normas e os documentos normativos são documentos abrangidos por direitos de Propriedade Intelectual a qual inclui a Propriedade Industrial, Direitos de Autor e Direitos Conexos. É proibida e punida, nos termos da legislação aplicável, a sua reprodução, utilização, distribuição ou divulgação pública, de qualquer parte deste documento, em qualquer formato, eletrónico ou mecânico, incluindo fotocópia ou colocação na internet ou numa intranet, sem autorização prévia escrita. A autorização deve ser requerida ao Instituto Português da Qualidade enquanto Organismo Nacional de Normalização.

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Contents Page

1 SCOPE ................................................................................................................................................................. 5

2 GENERAL PRESENTATION ............................................................................................................................ 5

2.1 MODEL A .............................................................................................................................................................................................. 5

IDENTIFICATION ........................................................................................................................................................................................ 5

2.2 MODEL B .............................................................................................................................................................................................. 6

IDENTIFICATION ................................................................................................................................................ 6

2.3 MODEL C .............................................................................................................................................................................................. 7

IDENTIFICATION ........................................................................................................................................................................................ 7

3 DIMENSIONS ..................................................................................................................................................... 8

3.1 MODEL A .............................................................................................................................................................................................. 8

3.2 MODEL B .............................................................................................................................................................................................. 9

3.3MODEL C .............................................................................................................................................................................................10

4 REQUIREMENTS ........................................................................................................................................... 10

4.1 MATERIALS ........................................................................................................................................................................................10

4.2 EVALUATION AND ACCEPTANCE CRITERIA ................................................................................................................................11

5 INFORMATION TO BE PROVIDED TO THE END USER ........................................................................ 11

5.1 LEVEL ..................................................................................................................................................................................................11

5.2 MANUFACTURER OR SUPPLIER IDENTIFICATION .....................................................................................................................12

5.3 COMPOSITION ...................................................................................................................................................................................12

5.4 SIZE IDENTIFICATION ......................................................................................................................................................................12

5.5 INSTRUCTIONS FOR USE..................................................................................................................................................................12

5.6 PICTOGRAM WITH INSTRUCTIONS ON PUTTING ON A MASK .................................................................................................13

5.7 PICTOGRAM WITH INSTRUCTIONS ON REMOVING THE MASK ...............................................................................................14

5.8 IDENTIFICATION OF THE RIGHT AND THE REVERSE ................................................................................................................14

5.9 SERVICE LIFE INDICATION .............................................................................................................................................................14

5.10 IDENTIFICATION OF CONSERVATION AND CLEANING CONDITIONS ..................................................................................14

5.10.1 CARE LABELLING .......................................................................................................................................................................14

5.11 LIMITATIONS ON USE ...................................................................................................................................................................15

5.12 CHILDREN’S MASKS .......................................................................................................................................................................15

Annex ......................................................................................................................................................................................................... 16

6 INFORMATION TO BE PROVIDED BY THE MANUFACTURER TO THE AUTHORITIES ................ 17

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Introduction

This reusable mask is intended to serve as a barrier mask to complement the protection measures and the rules of social distance, and can never override the protection measures and rules of social distance, fundamental for the control of COVID-19.

In addition, these masks are not for use by healthcare professionals in the performance of their duties, nor are they a medical device. Thus, they do not comply with the regulation of surgical masks (regulation EU/2017/745) or individual protection equipment (regulation EU / 2016/425).

These masks are intended for use by people when they leave their homes to travel to their workplace, school or business premises, to help protect the community.

This document also specifies the minimum protection requirements for reusable masks, for two specific applications:

• Level 2: masks intended for use by non-health professionals are exposed to contact with a large number of individuals.

• Level 3: masks designed to promote group protection (use by individuals in the context of their professional activity, use by individuals who contact other individuals with any type of mask and use in authorized exits in the context of confinement, namely in spaces multiple people).

These masks shall be used for a maximum period of 4 hours, and shall be changed whenever they are wet. They should also be washed using a complete wash cycle at 60 ° C with detergent and can only be used after being well dried.

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1 Scope

This document specifies the minimum requirements for reusable masks, for two specific applications:

Level 2: masks intended for use by non-health professionals are exposed to contact with a large number of individuals..

Level 3: masks designed to promote group protection (use by individuals in the context of their professional activity, use by individuals who contact other individuals with any type of mask and use in authorized exits in the context of confinement, namely in spaces multiple people).

2 General presentation

2.1 Model A

Right side

Inside out side

Identification

Section (M, W, C): Men/Women/Children

Article: Resusable Community Mask – Model A

Brief description:

Reusable mask for face protection. With three folds and fixation on the ears through elastic, with integrated nose support on the outside or inside, provided that it is properly secured (nasal clip easy to adjust). Conventional or unconventional seams can be used, such as, heat sealing, ultrasound or high frequency. Not sterile. Machine washable at 60 °C with detergent.

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2.2 Model B

Front view Side view

Identification


Article: Resusable Community Mask – Model B

Brief description:

Reusable mask for face protection. Union of external components of the nose and chin area made by seams, which guarantee resistance to the processes of conservation and cleaning. Elastic around the head and with integrated nose support on the outside or inside as long as properly secured (nasal clip easy to adjust). Not sterile. Machine washable at 60 °C with detergent.

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2.3 Model C

Upper view Bottom view

Front view Side view

Identification


Article: Resusable Community Mask – Model C

Brief description:

Reusable mask for face protection. Top view with one fold and bottom view with two folds. Union of external components of the nose and chin area made by seams, which guarantee resistance to the processes of conservation and cleaning. Elastic around the head and with integrated nose support on the outside or inside as long as properly secured (nasal clip easy to adjust). Not sterile. Machine washable at 60 °C with detergent.

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3 Dimensions

The measurement points are those shown below in the diagrams; the values for the respective sizes are in the measurement table, at the end of each sub clause.

3.1 Model A

Guiding measures table

Parameter vs dimension [cm] Adult size Children size

(6-9 years)

Children size

(10-12 years)

A Length 17,5-20 14-15 15-16

B Height with closed pleats 9,5-11 4-5,5 5,5-7

C Elastic length 14-17 9-12 9-12

D Nasal clip length 9-12 6-8 8-9

Height with open pleats 16,5-18 11-12 12-13

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3.2 Model B



(6-9 years)

Children size

(10-12 years)

A Length 13,5 8,5 9,5

B Height 15 11 12

C Length of the upper part 5,5 3 3,5

D Length of the bottom part 9 4 4,5

E Length of the upper elastic 34 26 28

F Length of the bottom elastic 22 14 16

G Nasal clip length 9-12 6-8 8-9

NOTE 1: If the textile structure is knitted fabric, the indicated measures must be checked after pre-washing, to ensure compliance with the guiding measures, throughout the product’s life cycle.

NOTE 2: The measures must be checked after the number of washing cycles recommended by the manufacturer.

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3.3Model C



(6-9 years)

Children size

(10-12 years)

A Length of the widest part 20 16-17 17-18

B Length of the narrowest part 16 12-13 13-14

C Height 6,5 4,5 5,5

D Total length of elastic 18 9-12 9-12

E Nasal clip length 9-12 6-8 8-9

Height with open pleats 22 11-12 12-13

NOTE 1: If the textile structure is knitted fabric, the indicated measures must be checked after pre-washing, to ensure compliance with the guiding measures, throughout the product’s life cycle.

NOTE 2: The measures must be checked after the number of washing cycles recommended by the manufacturer.

4 Requirements

4.1 Materials

Properties Standard /

method Requirement

Construction and

composition ---

Simple or combined textile structures of

non-woven, woven or knitted fabrics.

Its composition can be made of synthetic

or natural fibres and their mixtures, in

accordance with the required

requirements.

Mass per unit area EN 12127 20 a 500 g/m2

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4.2 Evaluation and acceptance criteria

Reusable masks shall consider compliance with filtering capacity and breathability as minimum requirements. The mask shall guarantee compliance with the requirements throughout the product's life cycle (the supplier shall include the number of washing/drying cycles to which the product shall be subjected, and must be at least 5).

The CITEVE's method for the evaluation of the filtration capacity of the masks (MI 142-CITEVE) is based on the determination of the Particle Retention Capacity (PRC).

Thus, the acceptance criteria are:

Level 2 Level 3

Particle

Retention

Capacity (PRC)

PRC (greater than or equal to, at 3µm) ≥

90 % According to MI 142 - CITEVE

Or

BFE ≥ 90 %

According to EN 14683:2019 (Annex

B)

Or

P ≤ 20 % (paraffin oil and NaCl)

According to EN 13274-7:2019

PRC (greater than or equal to, at 3µm) ≥

70 % According to MI 142 - CITEVE

Or

BFE ≥ 70 %

According to EN 14683:2019 (Annex B)

Or

P ≤ 30 % (paraffin oil and NaCl)

According to EN 13274-7:2019

Air

permeability

Air flow ≥ 8 l/min

According to EN ISO 9237:1995

Test conditions: Test area: 20cm2; Pressure used: 40 Pa

Or

Differential pressure ≤ 40 Pa

According to EN 14683:2019 (Annex C)

NOTE: Compliance with the minimum requirements shall be verified after the number of washing cycles identified by the manufacturer, which should be at least 5 cycles.

5 Information to be provided to the end user

The manufacturer shall add to the masks a leaflet with information to the end user, namely the information that allows its proper use.

5.1 Level

Level 2: masks intended for use by non-health professionals that are exposed to contact with a large number of individuals.

or

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Level 3: masks intended for use by individuals in the context of their professional activity or in authorized outlets in the context of confinement, namely in interior spaces with multiple people.

5.2 Manufacturer or supplier identification

Name and full address of the manufacturer, trademark or code and lot.

5.3 Composition

Indication of the composition of raw materials.

5.4 Size identification

Size identification (children / adult).

5.5 Instructions for use

The manufacturer shall provide information that allows the proper use of the mask, including:

This mask shall be used as a complement to the recommended protection and hygiene measures and to the rules of social distance, which are essential for the control of COVID-19. For more information, see https://covid19.min-saude.pt.

The reusable mask shall be handle correctly. The following instructions are recommend for the correct use of the mask, according to DGS Guideline (nº 019/2020 of 03/04/2020):

a) Hand hygiene, wash hands with soap and water or an alcohol-based solution, before putting on the mask.

b) Putting on the mask with the inner face facing the face, and the outer face facing out.

c) Adjust the nasal clip of the mask to the nose, covering the mouth, nose and chin with the mask, making sure that there are no spaces between the face and the mask.

d) The mask shall not be touched while it is in use; if this happens, hand hygiene should be performed immediately.

e) It is recommended to use each mask for a maximum period of 4 hours a day, and the mask should be replaced with a new one at the end of that period or as soon as it is wet. The removed mask must be washed before being reused.

f) If you accidentally wet the mask, replace it with a dry one as soon as possible. The wet mask must be washed before being reused.

g) The mask shall be removed from the back (not touching the front of the mask), holding the ties or elastics.

h) The mask should be placed individually in a closed plastic bag, until it is placed in the washing machine.

i) A new hand hygiene shall be performed at the end of the use and handling of the mask.

The mask should be washed before new use, and shall comply with the requirements indicated in the Table in subclause 5.2, after the number of washing cycles indicated in the information leaflet, which must be at least 5 cycles.

The protection of the mask is only guaranteed if you follow the cleaning and maintenance instructions that follow.

https://covid19.min-saude.pt/

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The mask should be stored in a dry environment and protected from potential contamination.

The mask should be washed before its first use.

In case of defect or damage do not use the mask, replace it with another one.

At the end of the mask's life cycle, wash the mask under the conditions defined in the “conservation and cleaning” section and after washing, it should be discard as a non-hazardous textile waste. If you choose not to wash the mask, you should discard it as biological waste.

5.6 Pictogram with instructions on putting on a mask

NOTE: throughout this document, the symbol is used to indicate adult supervision.

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5.7 Pictogram with instructions on removing the mask

5.8 Identification of the right and the reverse

Identification on the mask of which face is the inner and outer (through colour or another characteristic that leaves no doubt to the end user).

5.9 Service life indication

Maximum number of washing cycles in which the mask's protective performance is guarantee.

5.10 Identification of conservation and cleaning conditions

The masks shall be wash using a normal washing cycle at 60 °C (domestic type 6N wash, according to EN ISO 6330:2012) with detergent, after each use. The user shall ensure that the mask is dry before using it.

5.10.1 Care labelling

The following two symbols are mandatory:

Machine wash temperature at 60 ºC (normal process)

Does not allow dry cleaning

The rest of the cleaning symbols are the responsibility of the mask manufacturer, depending on the materials used in its preparation.

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5.11 Limitations on use

Place a warning, for example:

“This device is not a medical device. It does not comply with the regulation of surgical masks

(Regulation (EU) 2017/745) or individual protection equipment (Regulation (EU) 2016/425)”.

The mask shall be used very dry after washing. The wet / damp mask decreases the protection of

the mask.

The mask shall only be used by someone else after washing.

If you accidentally get your mask wet, replace it with a dry one as soon as possible. The wet mask

shall be washed before being reuse.

At the end of the recommended daily use or whenever you return home, the mask should be washed

before being reused.

5.12 Children’s masks

In the case of children's masks, place a warning such as:

The mask shall be put on and removed with adult supervision.

NOTE: throughout this document, the symbol is used to indicate adult supervision.

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Annex

As an illustration, you can find some possible material combinations and the fulfilment of the parameters identified as minimum requirements: particle retention capacity and air permeability. This information is only given as an example, and any combination of materials made does not exclude the need to test these two parameters.

Please see the link https://www.citeve.pt

https://www.citeve.pt/

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6 Information to be provided by the manufacturer to the authorities

The manufacturer shall send to ASAE the information requested in the link below for assessment prior to placing it on the market.

https://www.asae.gov.pt/covid-19-asae/esclarecimentos/fabrico-de-mascaras-para-uso-social-de-uso-unico-ou-reutilizavel-artigo-textil.aspx



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