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ISO 10993-14
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-14:2001

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

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ISO 10993-15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-15:2019

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

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ISO 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-16:2017

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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ISO 10993-17
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
ISO 10993-17:2023

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents

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ISO 10993-18
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

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ISO 10993-2
Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-2:2022

Biological evaluation of medical devices - Part 2: Animal welfare requirements

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ISO 10993-23
Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation

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ISO 10993-3
Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
ISO 10993-3:2026

Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity

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ISO 10993-4
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO 10993-4:2017

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

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ISO 10993-5
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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ISO 10993-6 PDF Preview
ISO 10993-6:2026

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

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ISO 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2026

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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ISO 10993-9
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-9:2019

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

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ISO 1101
Geometrical product specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation, location and run-out
ISO 1101:2017

Geometrical product specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation, location and run-out

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ISO 11011
Compressed air - Energy efficiency - Assessment
ISO 11011:2013

Compressed air - Energy efficiency - Assessment

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ISO 11014
Safety data sheet for chemical products - Content and order of sections
ISO 11014:2009

Safety data sheet for chemical products - Content and order of sections

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ISO 11040-4
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
ISO 11040-4:2024

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

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ISO 11040-6
Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
ISO 11040-6:2019

Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

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ISO 11040-7 PDF Preview
ISO 11040-7:2024

Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling

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ISO 11040-8
Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes
ISO 11040-8:2026

Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes

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ISO 11070
Sterile single-use intravascular introducers, dilators and guidewires
ISO 11070:2014

Sterile single-use intravascular introducers, dilators and guidewires

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ISO 11130
Corrosion of metals and alloys - Alternate immersion test in salt solution
ISO 11130:2017

Corrosion of metals and alloys - Alternate immersion test in salt solution

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ISO 11133
Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of culture media
ISO 11133:2014

Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of culture media

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ISO 11135
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

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ISO 11137-1 PDF Preview
ISO 11137-1:2025

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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