Do Our Medical Coolers Have WHO PQS Protocols?
The WHO PQS protocols are not Standards. They only apply to products that are used by WHO (UNICEF)direct use, or by countries or agencies that have received WHO funding. “PQS” is an acronym, simply meaning “Performance Quality Safety”
We elect for our Medical Cooler Products to carry a CE Mark, and comply with the EC Directive 92/42 EEC, as a Medical Device meeting the criteria for Class 1 in Annex IX of that Directive. These Standards, unlike the WHO protocols, are recognized as having a much wider global presence than the WHO protocols. However, if a customer is answering a request for tender from a WHO agency, we are pleased to verify compliance with the relevant PQS protocol, the cost of which being for the Customer.
To comply with 92/42/EEC, we are obliged to comply with these Standards:
- EN 724:1995 - Guidance on the application of EN 46001 (ISO 9001:2008) and EN 46002 (ISO 9002) for non-active Medical Devices
- EN 46001:1997 - Specification for the application of ISO 9001 to the manufacture of Medical Devices
- EN ISO 11197:2009 (Formerly EN 793:1998) - Medical Supply Units
- EN 980:2008 - Graphical Symbols for Medical Device Labelling
- EN 1042:2008+A1:2013 - Medical Devices, application of Risk Management
- ISO 20282-1:2006 - General product safety, ease of operation and design requirements for context of use and user characteristics
- IES 60529 - Ingress Protection. Degrees of Protection provided by enclosures (IP Code)
We supply: The UK NHS health service, Boots Healthcare