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Harmonized standards. Machinery directive



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Number of results 988

UNE
In force
2024-11-06

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions (ISO 11139:2018/Amd 1:2024)

UNE
In force
2024-11-01

Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE
In force
2024-11-01

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE
In force
2024-09-25

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)

UNE
In force
2024-06-01

Medical electrical equipment - Part 1: General requirements for safety

UNE
In force
2024-05-01

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in May of 2024.)

UNE
In force
2024-03-01

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use (Endorsed by Asociación Española de Normalización in March of 2024.)

UNE
In force
2024-02-01

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Endorsed by Asociación Española de Normalización in February of 2024.)

UNE
In force
2023-06-01

Laboratory glassware - Petri dishes (ISO 13132:2023) (Endorsed by Asociación Española de Normalización in June of 2023.)

UNE
In force
2023-04-01

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in April of 2023.)

UNE
In force
2023-02-22

Assistive products - Classification and terminology (ISO 9999:2022)

UNE
In force
2022-12-01

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by Asociación Española de Normalización in December of 2022.)

UNE
In force
2022-09-21

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

UNE
In force
2022-07-27

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

UNE
In force
2022-06-22

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

UNE
In force
2022-03-16

Absorbent incontinence products for urine and/or faeces - Product type names and illustrations (ISO 22748:2021)

UNE
In force
2022-03-16

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

UNE
In force
2022-03-01

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (Endorsed by Asociación Española de Normalización in March of 2022.)

UNE
In force
2021-12-07

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

UNE
In force
2021-12-01

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in December of 2021.)

UNE
In force
2021-12-01

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (Endorsed by Asociación Española de Normalización in December of 2021.)

UNE
In force
2021-09-22

Dentistry - Vocabulary (ISO 1942:2020)

UNE
In force
2021-09-22

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

UNE
In force
2021-09-08

Accessibility and usability of the built environment - Functional requirements

Number of results 988