DIN EN ISO 11607-1:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
DIN EN ISO 11979-3:2013-04
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012) |
DIN EN ISO 11979-1:2013-01
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012) |
ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
DIN EN ISO 11979-9:2014-12
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014) |
DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
DIN EN ISO 11979-10:2014-12
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014) |
DIN EN ISO 11979-4:2013-01
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012) |
DIN EN ISO 11979-2:2014-12
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014) |
DIN EN ISO 11979-5:2010-11
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Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
DIN EN ISO 10993-5:2009-10
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
ASTM F 1929 : 2015 : REDLINE
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Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
ISO 2233:2000
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Packaging Complete, filled transport packages and unit loads Conditioning for testing |
ISO/TR 22979:2017
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Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
DIN EN ISO 10993-12:2012-10
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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
DIN EN ISO 11607-2:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
ISO 10993-12:2012
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Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
ISO 11979-1:2006
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Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
DIN EN ISO 11979-8:2016-04 (Draft)
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
DIN EN ISO 11979-7:2014-12
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014) |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ISO 2248:1985
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Packaging Complete, filled transport packages Vertical impact test by dropping |
ISO 8318:2000
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Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency |