FICHA TÉCNICA - M&M Protek€¦ · E U Ty p e E x a m i n a t i o n C e r t i f i c a t e N o. C E...

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FICHA TÉCNICA Tampão Auditivo Reutilizável Ultrafit Ref. 202670 Especificações: - Tampão auditivo reutilizável com cordão de baixa atenuação. - Material suave e de óptima comodidade ao contacto com o canal auditivo. - Forma cónica e desenho com três anéis de alta resistência, permitem uma cómoda adaptação do protector à maior parte os canais auditivos. - Compatível com capacetes e óculos de protecção. - Fácil de limpar. - Resistente à humidade. - Atenuação: 14 dB (SNR) - Material: Silicone hipoalérgico SNR=14dB H=22dB, M=10dB, L=5dB Campo de Aplicação: - Recomendado para protecção ao ruído em variadas aplicações, tais como, indústria do metal, reparação automóvel, construção, indústria têxtil, indústria química e farmacêutica, imprensa, trabalhos com madeira, engenharia, entre outros.

Transcript of FICHA TÉCNICA - M&M Protek€¦ · E U Ty p e E x a m i n a t i o n C e r t i f i c a t e N o. C E...

Page 1: FICHA TÉCNICA - M&M Protek€¦ · E U Ty p e E x a m i n a t i o n C e r t i f i c a t e N o. C E 7 0 6 3 1 0 F i r s t Is s u e d : 2 0 1 9 - 0 3 - 2 2 E ffe c t i ve D a t e :

FICHA TÉCNICA

Tampão Auditivo Reutilizável Ultrafit Ref. 202670

Especificações:

- Tampão auditivo reutilizável com cordão de baixa atenuação.

- Material suave e de óptima comodidade ao contacto com o canal auditivo.

- Forma cónica e desenho com três anéis de alta resistência, permitem uma

cómoda adaptação do protector à maior parte os canais auditivos.

- Compatível com capacetes e óculos de protecção.

- Fácil de limpar.

- Resistente à humidade.

- Atenuação: 14 dB (SNR)

- Material: Silicone hipoalérgico

SNR=14dB H=22dB, M=10dB, L=5dB

Campo de Aplicação:

- Recomendado para protecção ao ruído em variadas aplicações, tais como,

indústria do metal, reparação automóvel, construção, indústria têxtil, indústria

química e farmacêutica, imprensa, trabalhos com madeira, engenharia, entre

outros.

Page 2: FICHA TÉCNICA - M&M Protek€¦ · E U Ty p e E x a m i n a t i o n C e r t i f i c a t e N o. C E 7 0 6 3 1 0 F i r s t Is s u e d : 2 0 1 9 - 0 3 - 2 2 E ffe c t i ve D a t e :

EU Type Examination CertificateNo. CE 706310

First Issued: 2019-03-22 Effective Date: 2019-04-08Latest Issue: 2019-04-08 Expiry Date: 2024-03-22

Page: 1 of 5This certificate has been issued by and remains the property of BSI Assurance UK Ltd, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UnitedKingdom and should be returned immediately upon request.To check its validity telephone +44 (0) 345 080 9000. An electronic certificate can be authenticated online.

BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

EU Type Examination Certificate

This is to certify that: 3M United Kingdom Plc3M CentreCain RoadBracknellBerkshireRG12 8HTUnited Kingdom

Holds Certificate Number: CE 706310

In respect of:

Personal hearing protection to EN 352-2:2002 based on Technical Specification 3M TS0526 -Ear-plugsModels: 3M™ UltraFit™ 14, 3M UltraFit™ 20 and 3M Tracers™ 20. on the basis that BSI carried out the relevant Type Examination procedures under the requirements with theRegulation (EU) 2016/425 of the European Parliament and Council relating to Personal Protective EquipmentRegulation (PPE) Annex V (Module B) and meets the relevant health and safety requirements specified in Annex II

For and on behalf of BSI, a NotifiedBody for the above Regulation (Notified Body Number 0086): Chris Lewis - Certification Director, Product Certification

First Issued: 2019-03-22 Effective Date: 2019-04-08Latest Issue: 2019-04-08 Expiry Date: 2024-03-22

Page: 1 of 5

This certificate has been issued by and remains the property of BSI Assurance UK Ltd, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UnitedKingdom and should be returned immediately upon request.To check its validity telephone +44 (0) 345 080 9000. An electronic certificate can be authenticated online.

BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Page 3: FICHA TÉCNICA - M&M Protek€¦ · E U Ty p e E x a m i n a t i o n C e r t i f i c a t e N o. C E 7 0 6 3 1 0 F i r s t Is s u e d : 2 0 1 9 - 0 3 - 2 2 E ffe c t i ve D a t e :

EU Type Examination CertificateNo. CE 706310

First Issued: 2019-03-22 Effective Date: 2019-04-08Latest Issue: 2019-04-08 Expiry Date: 2024-03-22

Page: 2 of 5This certificate has been issued by and remains the property of BSI Assurance UK Ltd, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UnitedKingdom and should be returned immediately upon request.To check its validity telephone +44 (0) 345 080 9000. An electronic certificate can be authenticated online.

BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Product Specification

Product Name: 3M™ Re-usable Earplugs.

Product Type: Hearing protectors – ear-plugs.

Model:(standard industrial products)

E-A-R™ Ultrafit™ 14E-A-R™ Ultrafit™ 20E-A-R™ Tracers™ 20.

Technical Specification: 3M TS0526 - based on Harmonized European Standard: EN 352-2:2002 (see below).

Product Description: The reusable ear-plugs are designed for insertion into the ear canal. The end userhas the option of fitting the supplied connecting cord to the earplugs.

Classification: Reusable (as per EN 352-2:2002 based definition)

Product AssessmentThe product assessments were based on Technical Specification 3M TS0526. The Specification was based entirely onEN 352-2:2002, the English language version of EN 352-2:2002, hearing protectors – ear-plugs apart from havingrelaxed minimum attenuation requirements at the frequencies 125 Hz, 250 Hz or 500 Hz as applicable to protectormodel, see below. This modification to the attenuation requirements was to ensure the end user would be providedwith protection against high noise exposure but not have their ability to hear low/moderate noise such as important andemergency signals compromised.

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EU Type Examination CertificateNo. CE 706310

First Issued: 2019-03-22 Effective Date: 2019-04-08Latest Issue: 2019-04-08 Expiry Date: 2024-03-22

Page: 3 of 5This certificate has been issued by and remains the property of BSI Assurance UK Ltd, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UnitedKingdom and should be returned immediately upon request.To check its validity telephone +44 (0) 345 080 9000. An electronic certificate can be authenticated online.

BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Attenuation valuesUltrafit 14:

Test Frequency f (Hz) 63 125 250 500 1000 2000 4000 8000

Mean Attenuation Mf (dB) 4.2 4.5 5.9 9.0 15.4 23.4 30.0 29.9

Standard Deviation Sf (dB) 2.4 2.6 2.0 2.7 3.0 3.0 3.6 2.7

Assumed Protection Value APVf (dB)(APVf = Mf-Sf)

1.8 1.9(1)

3.9(1)

6.3(1)

12.4 20.4 26.4 27.2

(1) Lower than EN 352-2 requirement – TS 526 based performance.

High, Medium and Low Frequency Attenuation Value and Single Number Rating

High Frequency Attenuation Value (H) 19dB

Medium Frequency Attenuation Value (M) 11dB

Low Frequency Attenuation Value (L) 6dB

Single Number Rating (SNR) 14dB

Sizing Nominal diameter: Smallest size : 7mm Largest Size: 12mm

Ultrafit 20:

Test Frequency f (Hz) 63 125 250 500 1000 2000 4000 8000

Mean Attenuation Mf (dB) 7.4 9.1 12.9 19.4 22.8 27.6 32.6 36.8

Standard Deviation Sf (dB) 4.0 6.0 4.5 5.0 3.7 2.9 3.6 3.9

Assumed Protection Value APVf (dB)(APVf = Mf-Sf)

3.4 3.1(1)

8.4 14.4 19.1 24.7 29.0 32.9

Lower than EN 352-2 requirement – TS 526 based performance.

High, Medium and Low Frequency Attenuation Value and Single Number Rating

High Frequency Attenuation Value (H) 25dB

Medium Frequency Attenuation Value (M) 17dB

Low Frequency Attenuation Value (L) 10dB

Single Number Rating (SNR) 20dB

Sizing Nominal diameter: Smallest size : 6mm Largest Size: 12mm

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EU Type Examination CertificateNo. CE 706310

First Issued: 2019-03-22 Effective Date: 2019-04-08Latest Issue: 2019-04-08 Expiry Date: 2024-03-22

Page: 4 of 5This certificate has been issued by and remains the property of BSI Assurance UK Ltd, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UnitedKingdom and should be returned immediately upon request.To check its validity telephone +44 (0) 345 080 9000. An electronic certificate can be authenticated online.

BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Tracers 20:

Test Frequency f (Hz) 63 125 250 500 1000 2000 4000 8000

Mean Attenuation Mf (dB) 8.6 8.5 13.4 20.6 24.9 25.5 33.8 36.4

Standard Deviation Sf (dB) 4.6 6.1 5.6 2.1 3.6 4.4 8.1 3.7

Assumed Protection Value APVf (dB)(APVf = Mf-Sf)

4.0 2.4(1)

7.8 (1) 18.5 21.3 21.1 25.7 32.7

Lower than EN 352-2 requirement – TS 526 based performance.

High, Medium and Low Frequency Attenuation Value and Single Number Rating

High Frequency Attenuation Value (H) 24dB

Medium Frequency Attenuation Value (M) 18dB

Low Frequency Attenuation Value (L) 10dB

Single Number Rating (SNR) 20dB

Sizing Nominal diameter: Smallest size : 6mm Largest Size: 12mm

Packaged variantsIn addition to the products referenced on this Certificate the standard industrial products may also be sold as marketspecific packaged variants. Such variants will be differentiated and the Technical File(s) will be updated with theappropriate information.

Kits and packoutsThe products referenced on this Certificate may also be combined with other 3M products into a kit or packout. Therewill be no change to the product but the User Information may vary, in such instances the applicable Technical File(s)will be updated with the appropriate information.

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EU Type Examination CertificateNo. CE 706310

First Issued: 2019-03-22 Effective Date: 2019-04-08Latest Issue: 2019-04-08 Expiry Date: 2024-03-22

Page: 5 of 5This certificate has been issued by and remains the property of BSI Assurance UK Ltd, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UnitedKingdom and should be returned immediately upon request.To check its validity telephone +44 (0) 345 080 9000. An electronic certificate can be authenticated online.

BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A member of BSI Group of Companies.

Certificate Administration Details

Technical File References:

Item Technical File

3M E-A-R Ultrafit 14, Ultrafit 20 and Tracers 20 TF0526

3M Re-usable Earplugs Generic User Instructions. TF0534.

Certificate Amendment Record:

Issue date Comments BSI Review No.March 2019

April 2019

First issue under PPE Regulation (EU) 2016/425.

Administration reissue for correction.

0086:19:9716221

Certificate validityThe Certificate holder is responsible for ensuring that the Notified Body is advised of changes to any aspect of theoverall process utilised in the manufacture of the product, failure to do so could invalidate the Certificate in respect ofproduct manufactured following the introduction of such changes.

The validity of the Certificate for the products is also dependent on the maintenance of the EU Conformity to TypeBased on Quality Assurance of the Production Process, Annex VIII (Module D), as referenced on BSI issued CertificateCE 595701.