ISO Standards

ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products.

This International Standard specifies requirements for the production of products used in the collection,storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis. The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and

ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled ‘sterile’ and to CBHPs not labelled ‘sterile’. This International Standard is not applicable to: — procurement and

ISO 18264:2016 specifies the requirements related to safety, including methods of rating and testing eye-and-eye and endless sling constructions used as single (1) leg, two (2) leg, three (3) leg or four (4) leg lifting configurations (with and without fittings).These sling constructions are made of 8-strand braided ropes (type L), 12-strand braided ropes (type T),

This International Standard specifies the general requirements common to airways and related equipment and applicable to those device-specific standards that reference it. The requirements of a device-specific standard take priority over this International Standard. NOTE General requirements contained in this International Standard have historically been referenced in more than two other airways and related equipment

This document specifies a method for the sampling and analysis of airborne organic isocyanates in workplace air. This document is applicable to a wide range of organic compounds containing isocyanate groups,including monofunctional isocyanates (e.g. phenyl isocyanate), diisocyanate monomers [e.g.1,6-hexamethylene diisocyanate (HDI), toluene diisocyanate (TDI), 4,4′-diphenylmethane diisocyanate (MDI), and isophorone diisocyanate (IPDI)], prepolymers (e.g. the biuret