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Technical rule [CURRENT]

ONR 111107-3

Quality management for supply with medical devices for rehabilitation - Part 3: Rehabilitation technical activities - Process quality for all devices
Edition 2008-08-01

Technical rule [CURRENT]

ONR 112069-1

Guideline for the validation and routine control of sterilization processes with moist heat for medical device products - Part 1: General
Edition 2009-07-01

Technical rule [CURRENT]

ONR 112069-2

Guideline for the validation and routine control of steam sterilization processes for medical devices in/for in health care institutions - Part 2: Further specifications
Edition 2009-07-01

Technical rule [CURRENT]

ONR CEN ISO/TS 16775

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
Edition 2022-05-15

Technical rule [CURRENT]

ONR 111107-5

Quality management for supply with medical devices for rehabilitation - Part 5: Wheelchairs - Selection and adaptation of electrically powered wheelchairs and auxiliary drive systems
Edition 2013-05-01

Technical rule [CURRENT]

ONR 111107-4

Quality management for supply with medical devices for rehabilitation - Part 4: Wheelchairs - Selection and adaptation of manually propelled wheelchairs
Edition 2011-08-01

Pre-standard

SN ENV 13004

Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
Edition 1999-10

Pre-standard

OENORM ENV 13004

Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
Edition 1999-10-01

Short range devices (SRD) - Ultra low power active medical membrane implants (ULP-AMI-M) and peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz - Harmonised standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1)
Edition 2017-06-17

ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 29: specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (V2.2.1)
Edition 2021-01-16

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