NA 176

DIN Standards Committee Health Technologies

DIN ISO 21881 [CURRENT] references following documents:

Document number Edition Title
ISO 11137-2 2013-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More 
ISO 11137-3 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control More 
ISO 11139 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More 
ISO 13926-3 2019-05 Pen systems - Part 3: Seals for pen-injectors for medical use More 
ISO 14644-1 2015-12 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration More 
ISO 14937 2009-10 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices More 
ISO 15378 2017-09 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) More 
ISO 2859-1 1999-11 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection More 
ISO 3951-2 2013-09 Sampling procedures for inspection by variables - Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics More 
ISO 3951-3 2007-05 Sampling procedures for inspection by variables - Part 3: Double sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection More