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СтандартыBSI

BS ISO 19227:2018

Действует
Implants for surgery. Cleanliness of orthopedic implants. General requirements — 26 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO/IEC 17025:2017
Действует
General requirements for the competence of testing and calibration laboratories — 38 стр.
ISO 2859-1:1999/Amd.1:2011
Действует
Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection -- Amendment 1 — 8 стр.
ISO 14644-15:2017
Действует
Cleanrooms and associated controlled environments -- Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration — 28 стр.
ISO 10993-17:2002
Действует
Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.
ASTM F2459-18
Действует
Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis — 8 стр.
BS EN 14844:2006
Действует
Precast concrete products. Box culverts — 42 стр.
BS ISO 3951-1:2013
Действует
Sampling procedures for inspection by variables. Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL — 106 стр.
BS EN 13018:2016
Действует
Non-destructive testing. Visual testing. General principles — 12 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
BS ISO 3951-2:2013
Действует
Sampling procedures for inspection by variables. General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics — 98 стр.
ASTM F3127-16
Заменен
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices — 16 стр.
ISO 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.
ISO 9377-2:2000
Действует
Water quality. Determination of hydrocarbon oil index. Part 2. Method using solvent extraction and gas chromatography — 24 стр.
ISO 11737-1:2006
Заменен
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products — 42 стр.
ISO 10993-5:2009
Действует
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.
ASTM D7066-04
Заменен
Standard Test Method for dimer/trimer of chlorotrifluoroethylene (S-316) Recoverable Oil and Grease and Nonpolar Material by Infrared Determination — 9 стр.
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.