Emergency COVID-19: standards to reduce contagion

Monday, 23 March 2020 08:53 Product safety
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These days there is a lot of talk about masks and other personal protective equipment to protect yourself from possible infections.
What are the standards that deal with this matter? Let's find out.

Below is a list of standards that can help in reducing contagion due to COVID-19. Some standards are related to Regulation (EC) 2016/425 on personal protective equipment and others to Directive 93/42/EEC for Medical devices.

 

EN 149:2001+A1: 2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking

Harmonised to Regulation (EC) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC.

Scope: the standard specifies minimum requirements for dust filter half-masks used as respiratory protective devices other than those intended for escape.

 

EN 166:2001 Personal eye-protection - Specifications

Harmonised to Regulation (EC) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC.

Scope: the standard defines the functional requirements for different types of personal eye-protectors and contains general considerations like designation, classification, requirements applicable to all eye-protectors, special and optional requirements, attribution of requirements, testing and application, marking and information for users.

It covers the personal eye-protectors used against hazards like those occurring in industry, laboratories, school buildings, domestic activities, etc., which can damage the eyes or compromise vision. It does not deal with the protection of the eyes against nuclear radiation, X-rays, laser beams and low temperature infrared (IR) radiation emitted from low temperature sources for which specific standards exist.

 

EN 455-1:2020 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN 455-1: 2000 harmonised to Directive 93/42/EEC for Medical devices. EN 455-1:2020 not yet harmonised.

Scope: part 1 identifies requirements and provides the test method for medical gloves for single use to determine freedom from holes.

 

EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties

EN 455-2:2009+A2:2013 harmonised to Directive 93/42/EEC for Medical devices. EN 455-2:2015 not yet harmonised.

Scope: the standard indicates requirements and provides test methods for physical properties of single-use medical gloves to ensure that they provide and keep an adequate level of protection from cross contamination for both patient and user.

 

EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Standard harmonised to Directive 93/42/EEC for Medical devices. EN 455-3:2015 not yet harmonised.

Scope: part 3 sets requirements for the evaluation of biological safety for medical gloves for single use. It provides requirements for labelling and the dissemination of information on the test methods used.

 

EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

Standard harmonised to Directive 93/42/EEC for Medical devices

Scope: part 4 deals with the labelling and the dissemination of information on the test methods used. It applies to existing, new and significantly changed designs.

 

EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

Standard not yet harmonised to Directive 93/42/EEC for Medical devices

Scope: the standard contains the information to be provided to users and third-party verifiers in addition to the usual labelling of medical devices contained in EN 1041 and EN ISO 15223-1 about manufacturing and processing requirements. It addresses the characteristics of single-use and reusable surgical drapes and gowns used as medical devices for patients, clinical staff and equipment and used to prevent the transmission of infectious agents between clinical staff and patients during surgery and other invasive procedures.

EN 13795-1 identifies the test methods to assess the identified characteristics of surgical drapes and gowns and establishes the performance requirements for these products. The standard does not cover the requirements for resistance to penetration of products with laser radiation.

 

EN 13795-2:2019 Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

Standard not yet harmonised to Directive 93/42/EEC for Medical devices

Scope: the standard identifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.

 

EN 14126:2003 (AC:2004) Protective clothing - Performance requirements and tests methods for protective clothing against infective agents

Harmonised to Regulation (EC) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC

Scope: the standard details the information to be available to users and third-party verifiers in addition to the usual labelling of medical devices included in EN 1041 and EN ISO 15223-1 about production and processing requirements.

 

EN 14605:2005+A1:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

Harmonised to Regulation (EC) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC

Scope: the standard indicates the minimum requirements for the following types of limited use and reusable chemical protective clothing: full-body protective clothing with liquid-tight connections, full-body protective clothing with spray-tight connections and partial body protection garments offering protection to specific parts of the body.

 

EN 14683:2019 Surgical masks - Requirements and test methods

EN 14683:2005 harmonised to Directive 93/42/EEC for Medical devices. EN 14683:2019 not yet harmonised.

Scope: the standard indicates the construction, design, performance requirements and test methods for medical face masks to limit the transmission of contagious agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier may also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.

 

EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)

Harmonised to Regulation (EC) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC

Scope: this part provides the requirements and test methods for protective gloves intended to protect the user against micro-organisms.

 

EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

Standard not yet harmonised to Directive 93/42/EEC for Medical devices

Scope: This document deals with the general principles governing the biological evaluation of medical devices within a risk management process, the categorization of medical devices based on the nature and duration of their contact with the body, the evaluation of existing relevant data from all sources, the identification of gaps in the available data set on the basis of a risk analysis, the identification of additional data sets necessary to analyse the biological safety of the medical device and the assessment of the biological safety of the medical device.

 

EN ISO 13688:2013 Protective clothing - General requirements (ISO 13688:2013)

Harmonised to Regulation (EC) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC

Scope: the standard introduces general performance requirements for ergonomics, innocuousness, size designation, ageing, compatibility and marking of protective clothing and the information to be provided by the manufacturer with the protective clothing.

59 Monday, 23 March 2020 10:10

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