PPE has included a number of guides for your perusal.
The first two guides are from the UK government outlining regulatory issues for manufactures wishing to supply to the UK market. It is essential that all suppliers read and understand that they are conforming to these rules.
The other guide is useful information for all buyers of PPE equipment. We have produced a guide to help you identify what to look for when purchasing products relating to PPE. We hope that this will educate you to ensure that you only select products to the appropriate quality to fully protect you, and your customers and staff from the Covid 19 pandemoic.
1. UK Government guidance for high volume manufacturers of COVID-19 PPE.
2. UK Government guidance for small scale manufactures of COVID-19 PPE.
3. Buyers Guidance for procurement of COVID-19 PPE.
PURCHASERS GUIDE FOR PERSONAL PROTECTIVE EQUIPMENT (PPE)
In accordance with the requirements of the Personal Protective Equipment Regulations 2016/425, manufacturers, importers and distributors of Personal Protective Equipment (PPE) need to ensure that only safe and compliant PPE is placed or made available on the market.
In order to ensure that you are only purchasing compliant PPE, the below information has been produced to help you carry out your due diligence:
All PPE should be provided with the following:
• Declaration of Conformity (DoC) which can be either with the product or available on manufacturer’s website for which a link should be provided and it must contain the following information as minimum: o Identification of product by name/serial number etc o Manufacturers name & address o Reference of compliance with PPE Regulation 2016/425 o Reference to Notified Body involved in Type examination process and the number of EU type examination certificate issued o Reference to Notified Body involved in quality assurance process o Reference to the standards used.
• CE marking on product and packaging. CE marking is accompanied by the four digit number of the Notified Body as explained below.
• PPE accompanied by instructions in English
PPE should be manufactured in accordance with a European Standard (see the table below) or a technical solution that ensures compliance with the PPE Regulations 2016/425.
For Category III PPE, which includes PPE that protects against “harmful biological agents” a notified body needs to be used to type-examine the product and to audit the quality assurance process A list of notified bodies which are formally appointed to carry out the above conformity assessment process can be found at the below website;
The details of notified body or bodies and its four digit identification code which are involved in both type examination and quality assurance should be found on the Declaration of Conformity. The CE marking on the product must also accompanied by four digit code of the Notified Body that was involved in quality assurance process. The four digit number can be found on the website link above.
European Standards for common types of PPE (Not exhaustive, but most relevant)
Should be stated on the Declaration of Conformity accompanying the PPE & in any accompanying test reports
BS EN 1276 (European Standard for biocidal regulations)
BS EN 455-1:2000 (Freedom from holes)
BS EN 455-2:2015 (Testing of physical properties)
BS EN 455-3:2015 (Testing for biological evaluation)
BS EN 455-4:2009 (Testing for service life determination)
BS EN ISO 374-2 (Protective gloves against chemicals & Micro-organisms)
Disposable halfmask respirators
BS EN 149:2001+A1:2009 (Requirements, testing, marking)
Reusable half mask respirator with particle filter
BS EN 140:1999 (Respiratory protective devices – requirements, testing, marking)
BS EN 166:2002 (Personal Eye Protection)
‘Red flags’ to look out for in documentation
• Reference to previous Directive (89/686).
• Declaration of Conformity (DoC) called ‘Certificate of Conformity, Compliance or something similar.
• Product described in DoC does not match packaging.
• Instructions do not match product or are not adequate or intelligible
• Unfamiliar/unrecognised Standard number
• Check date of Declaration
• Reference to a body not notified under the PPE Regulations