Basic environmental testing procedures - Part 2: Tests; test Ec: Drop and topple, primarily for equipment-type specimens (IEC 60068-2-31:1969 + A1:1982); German version EN 60068-2-31:1993— 6 стр.
Environmental testing - Part 2: Test methods; test Fh: Vibration, broad-band random (digital control) and guidance (IEC 60068-2-64:1993 + Corrigendum 1993); German version EN 60068-2-64:1994— 27 стр.
Classification of environmental conditions - Part 3: Classification of groups of environmental parameters and their severities - Section 7: Portable and non-stationary use (IEC 60721-3-7:1995); German version EN 60721-3-7:1995— 26 стр.
Acoustics - Determination of sound power levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:1995, including Cor 1:1995); German version EN ISO 3746:2009— 28 стр.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2009— 27 стр.
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); German version EN ISO 10993-4:2009— 50 стр.
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2009— 31 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008— 108 стр.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999); German version EN ISO 10993-9:2009— 18 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); German version EN ISO 10993-10:2009— 68 стр.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2009— 28 стр.
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998); German version EN ISO 10993-13:2009— 24 стр.
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009— 23 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000); German version EN ISO 10993-15:2009— 21 стр.
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); German version EN ISO 10993-16:2009— 21 стр.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009— 38 стр.
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009— 28 стр.
Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Engineering method in an essentially free field over a reflecting plane (ISO 11201:1995, including Cor 1:1997); German version EN ISO 11201:2009— 18 стр.
Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Survey method in situ (ISO 11202:1995); German version EN ISO 11202:2009— 19 стр.
Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Method requiring environmental corrections (ISO 11204:1995, including Cor 1:1997); German version EN ISO 11204:2009— 19 стр.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009— 32 стр.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009— 17 стр.
Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for proving conformance or non-conformance with specifications (ISO 14253-1:1998); German version EN ISO 14253-1:1998— 17 стр.
Electrical engineering; basic environmental testing procedures; test Db and guidance: damp heat, cyclic (12 + 12-hour cycle); identical with IEC 60068-2-30, edition 1980 (status as of 1985)
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995); German version EN ISO 7886-1:1996— 20 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007— 52 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007, Corrigendum to DIN EN ISO 11137-2:2007-09; German version EN ISO 11137-2:2007/AC:2009— 2 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009— 75 стр.
Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Guide to the estimation of uncertainty in GPS measurement, in calibration of measuring equipment and in product verification (ISO/TS 14253-2:1999)— 54 стр.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2009); German version prEN ISO 15223-1:2009
