New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
Product family grouping, as discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013, titled ‘Sterilization of Health Care Products...
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Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application
In March 2017, the new ISO 18562 standard series was released, comprising four parts that address the...
Packaging Design for Sterilization
Bringing a medical device from conception to market involves numerous critical steps, one of which is often...