ZH
RU
ES

Medicare Class A

Medicare Class A, Total:77 items.

In the international standard classification, Medicare Class A involves: Applications of information technology, Vocabularies, Sterilization and disinfection, Ergonomics, Quality, Medical sciences and health care facilities in general, Services, Electrical equipment for working in special conditions, Medical equipment, Laboratory medicine, Information sciences. Publishing, Occupational safety. Industrial hygiene, Protective equipment.

AENOR, Medicare Class A

UNE-ENV 12924:1998 MEDICAL INFORMATICS. SECURITY CATEGORISATION AND PROTECTION FOR HEALTHCARE INFORMATION SYSTEMS.
UNE-EN 50303:2001 Group I, Category M1 equipment intended to remain functional in atmospheres endangered by firedamp and/or coal dust.

Association Francaise de Normalisation, Medicare Class A

NF EN ISO 13120:2019 Informatique de santé - Syntaxe de représentation du contenu des systèmes de classification des soins de santé - Langage de marquage de la classification (ClaML)
NF S97-511:2013 Health informatics - Syntax to represent the content of healthcare classification system - Classification Markup Language (ClaML)
NF EN ISO 25424/A1:2022 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux - Amendement 1
NF EN ISO 25424:2019 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
NF S92-503:2013 Laboratory of medical biology - Anthroporadiometric measurements - Thyroid - Measurement of gamma-ray emissions of isotopes of iodine
NF S98-004-5:2006 Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes.
NF S92-503:2006 Medical biology analysis laboratory - Anthroporadimetric measurements - Thyroid countings - Measurements of gamma emitters of iodine isotopes.

CEN - European Committee for Standardization, Medicare Class A

DD ENV 12924-1997 Medical Informatics - Security Categorisation and Protection for Healthcare Information Systems

British Standards Institution (BSI), Medicare Class A

DD ENV 12924-1998 Medical informatics. Security categorisation and protection for healthcare information systems
BS EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Biological indicators for low-temperature steam and formaldehyde sterilization processes
BS EN ISO 11138-8:2021 Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
BS EN ISO 13120:2019 Tracked Changes. Health informatics. Syntax to represent the content of healthcare classification systems. Classification Markup Language (ClaML)
BS EN ISO 25424:2019+A1:2022 Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
PD ISO/TR 17302:2015 Nanotechnologies. Framework for identifying vocabulary development for nanotechnology applications in human healthcare
21/30427336 DC BS EN ISO 25424 AMD1. Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization

人力资源和社会保障部, Medicare Class A

LD/T 01-2017 Classification and codes of social insurance medical service items

国家药监局, Medicare Class A

YY/T 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products

European Committee for Standardization (CEN), Medicare Class A

CEN ISO/TR 12296:2013 Ergonomics - Manual handling of people in the healthcare sector
EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

International Organization for Standardization (ISO), Medicare Class A

ISO/TR 12296:2012 Ergonomics - Manual handling of people in the healthcare sector
ISO 13120:2019 Health informatics — Syntax to represent the content of healthcare classification systems — Classification Markup Language (ClaML)
ISO 25424:2018/Amd 1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment
ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

Korean Agency for Technology and Standards (KATS), Medicare Class A

KS P ISO 25424:2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS X ISO 13120:2021 Health informatics — Syntax to represent the content of healthcare classification systems — Classification Markup Language(ClaML)
KS G ISO 12609-1:2021 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products
KS G ISO 12609-1:2014 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products
KS G ISO 12609-2:2014 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 2: Guidance for use
KS G ISO 12609-2:2021 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 2: Guidance for use

KR-KS, Medicare Class A

KS P ISO 25424-2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS X ISO 13120-2021 Health informatics — Syntax to represent the content of healthcare classification systems — Classification Markup Language(ClaML)
KS G ISO 12609-2-2021 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 2: Guidance for use
KS G ISO 12609-1-2021 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products

Danish Standards Foundation, Medicare Class A

DS/EN ISO 13120:2013 Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML)
DS/EN 50303:2001 Group I, Category M1 equipment intended to remain functional in atmospheres endangered by firedamp and/or coal dust
DS/ISO 12609-1:2021 Eye and face protection against intense light sources used on humans and animals for cosmetic and medical applications – Part 1: Specification for products

German Institute for Standardization, Medicare Class A

DIN EN ISO 13120:2019-11 Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2019); German version EN ISO 13120:2019
DIN 6850:2006-12 Radiation protection containers, tables and safes for use in nuclear medicine - Requirements and classification
DIN EN ISO 13120:2019 Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2019)
DIN EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006
DIN EN ISO 25424:2020 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
DIN EN ISO 13120:2013 Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2013); German version EN ISO 13120:2013
DIN EN ISO 25424:2022-07 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022); German version EN ISO 25424:2019...
DIN CEN ISO/TR 12296:2013 Ergonomics - Manual handling of people in the healthcare sector (ISO/TR 12296:2012); German version CEN ISO/TR 12296:2013
DIN EN ISO 11138-5 Berichtigung 1:2007 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006, Corrigenda to DIN EN ISO 11138-5:2006-
DIN EN ISO 25424/A1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021); German and English vers
DIN EN ISO 12609-1:2019-10 Eye and face protection against intense light sources used on humans and animals for cosmetic and medical applications - Part 1: Specification for products (ISO/DIS 12609-1:2019); German and English version prEN ISO 12609-1:2019 / Note: Date of issue 2...

ES-UNE, Medicare Class A

UNE-EN ISO 13120:2019 Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2019) (Endorsed by Asociación Española de Normalización in July of 2019.)
UNE-EN ISO 25424:2020 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
UNE-EN ISO 25424:2020/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)

American National Standards Institute （ANSI), Medicare Class A

ANSI/ASTM E2117:2006 Classifications Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription
ANSI/AAMI/ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Sichuan Provincial Standard of the People's Republic of China, Medicare Class A

DB5104/T 24-2020 Part 2 of combined medical and elderly care service points: maternal and infant health care and childcare services

US-AAMI, Medicare Class A

ANSI/AAMI/ISO TIR17665-3:2014 Sterilization of health care products - Moist heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization
ANSI/AAMI PB70-2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

Lithuanian Standards Office , Medicare Class A

LST EN 50303-2003 Group I, category M1 equipment intended to remain functional in atmospheres endangered by firedamp and/or coal dust

UNKNOWN, Medicare Class A

GB/T 18281.5-2015 Biological Indicators for Sterilization of Healthcare Products Part 5: Biological Indicators for Formaldehyde Sterilization by Low Temperature Steam
GB/T 18282.5-2015 Chemical Indicators for Sterilization of Healthcare Products Part 5: Class II Indicators for Class BD Air Exclusion Tests

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medicare Class A

GB 18281.5-2015 Biological indicators for sterilization of healthcare products - Part 5: Biological indicators for formaldehyde sterilization by low temperature steam
GB 18282.5-2015 Chemical Indicators for Sterilization of Healthcare Products Part 5: Class II Indicators for Class BD Air Exclusion Tests
GB 18282.3-2009 Sterilization of health care products-Chemical indicators-Part3：Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
GB 18282.4-2009 Sterilization of health care products-Chemical indicators-Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

未注明发布机构, Medicare Class A

DIN EN ISO 25424:2022 Sterilization of healthcare products – Low temperature vapor formaldehyde – Requirements for the development, validation and routine monitoring of sterilization procedures for medical devices
BS EN ISO 25424:2018+A1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

AT-ON, Medicare Class A

ONORM S 5225-1994 Radiation protection Containers, tables and safes for use in nuclear medicine - Requirements and Classification - Marking of conformity
OENORM EN ISO 25424/A1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018/DAM 1:2021) (Amendment)

US-CFR-file, Medicare Class A

CFR 42-405.211-2013 Public Health. Part405:Federal health insurance for the aged and disabled. Section405.211:Procedures for Medicare contractors in making coverage decisions for a non-experimental/investigational (Category B) device.
CFR 42-405.213-2013 Public Health. Part405:Federal health insurance for the aged and disabled. Section405.213:Re-evaluation of a device categorization.
CFR 42-405.203-2013 Public Health. Part405:Federal health insurance for the aged and disabled. Section405.203:FDA categorization of investigational devices.
CFR 42-405.205-2013 Public Health. Part405:Federal health insurance for the aged and disabled. Section405.205:Coverage of a non-experimental/investigational (Category B) device.

GOSTR, Medicare Class A

GOST R 58163-2018 Sterilization of health care products. Moist heat. Part 3. Guidance on the designation of a medical device to a product family and processing category for steam sterilization