medical product labeling

medical product labeling, Total:157 items.

The international standard classification for "medical product labeling" includes: Medical equipment in general , Graphical symbols for use on specific equipment .

The Chinese standard classification for "medical product labeling" includes: Medical apparatus and devices in general , General requirements on medical devices .

Professional Standard - Medicine

YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied

Guangdong Provincial Standard of the People's Republic of China

DB4403/T 220-2021 Assignment Rules for Medical Device Product Identification

Jilin Provincial Standard of the People's Republic of China

DB22/T 1150-2018 black fungus product label

Gosstandart of Russia

GOST R ISO 15223-1-2010 Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. Part 1. General requirements
GOST R ISO 15223-2002 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied
GOST R 15.013-1994 System of product development and launching into manufacture. Medical products
GOST R 56429-2021 Medical devices. Clinical еvaluation
GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices
GOST R ISO 15223-1-2014 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
GOST R IEC 62366-1-2023 Medical devices. Part 1. Application of usabilityengineering to medical devices
GOST R ISO 15223-1-2020 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements

Association for the Advancement of Medical Instrumentation

AAMI ST67:2011(R2017) Sterilization of Health Care Products--Requirements for Products Labeled 'STERILE'
ANSI/AAMI ST67-2019 Sterilization of medical devices - Requirements for products labeled "STERILE"
ANSI/AAMI ST67-2003 Sterilization of medical devices - Requirements for products labeled "STERILE"
ANSI/AAMI/ISO 15223-1:2012 Medical devices.Symbols to be used with medical device labels, labeling, and information to be supplied.Part 1: General requirements
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

North Atlantic Treaty Organization Standards Agency

STANAG 2347-2008 MEDICAL WARNING TAG
STANAG 2347-2017 MEDICAL WARNING SHEET (ED 3)
AMEDP-8.8-2017 MEDICAL WARNING TAG (ED A@ Ver. 1)

ET-QSAE

ES 545-2000 General Standard for Product Labeling of Pharmaceutical, Medicinal or Herbal Product Packaging
ES 546-2000 General Standard for Direct Container Labeling of Medicinal, Medicinal or Crude Drug Products

International Organization for Standardization (ISO)

ISO/TR 15223:1998 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 15223:2000/Amd 1:2002 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 1
ISO 15223:2000/Amd 2:2004 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

Korean Agency for Technology and Standards (KATS)

KS P ISO 15223-2007(2012) Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 15223-2019 Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 15223:2007 Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 15223-1:2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
KS P ISO 15223-1-2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
KS P ISO 15223-2-2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
KS P ISO 15223-2:2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
KS P ISO 15223-2-2019(2024) Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

British Standards Institution (BSI)

DD ENV 12610:1998 Medical informatics. Medical product identification
BS DD ENV 12610:1998 Medical informatics - Medical product identification
09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
BS EN 980:2008 Symbols for use in the labelling of medical devices
BS EN 980:1997 Graphical symbols for use in the labelling of medical devices
06/30122245 DC EN 980. Symbols for use in the labelling of medical devices
BS EN 980:2003 Graphical symbols for use in the labelling of medical devices
DD ENV 12610-1998 Medical informatics. Medical product identification
BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied-General requirements
09/30176675 DC BS EN ISO 15223-1. Medical devices. Symbols to be used with medical device labels , labelling and information to be supplied. Part 1. General requirements
BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS EN ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS BIP 3083:2009 Graphical symbols for use in the labelling of medical devices CD-ROM
08/30154605 DC BS ISO 15223-2. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 2. Symbol development, selection and validation
20/30387822 DC BS EN ISO 15223-1. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1. General requirements
19/30401046 DC BS EN ISO 15223-1 AMD1. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied - Part 1. General requirements

Association Francaise de Normalisation

NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
NF S99-004:2008 Symbols for use in the labelling of medical devices.
NF EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for the labeling of medical devices containing phthalates
NF S99-004:1996 Graphical symbols for use in the labelling of medical devices.
NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to obtain STERILE labeling - Part 1: Requirements for terminally sterilized medical devices
NF S98-107:1998 Sterilization of medical devices. Requirements for terminally-sterilized medical devices to be labelled "Sterile".
NF ISO 15223-2:2010 Medical devices - Symbols for use with labels, labeling and information requirements relating to medical devices - Part 2: development, selection and validation of symbols
NF EN 1641:2009 Dental Art - Medical Devices for Dental Art - Products

Ente Nazionale Italiano di Unificazione

UNI CEI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNI CEI EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
EC 1-2017 UNI CEI EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
UNI CEI EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
UNI EN 556:2000 Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"
UNI ENV 12388:1996 Medical informatics. Algorithm for Digital Signature Services in Health Care.

Swedish Institute for Standards

SS-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
SS-EN 980:2003 Graphical symbols for use in the labelling of medical devices
SS-EN 980/A2:2001 Graphical symbols for use in the labelling of medical devices
SS-EN 980/A1:2000 Graphical symbols for use in the labelling of medical devices
SIS-ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities (ISO/TS 22421:2021)

Spanish Association for Standardization (UNE)

UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
UNE-EN 980:2008 Symbols for use in the labelling of medical devices
UNE-EN 980:2004 Graphical symbols for use in the labelling of medical devices

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
LST EN 980-2008 Symbols for use in the labelling of medical devices
LST EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

Danish Standards Foundation

DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
DANSK DS/EN 980:2008 Symbols for use in the labelling of medical devices
DS/EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
DANSK DS/ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
DANSK DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation

European Committee for Standardization (CEN)

EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
CEN EN 980-2008 Symbols for use in the labelling of medical devices
EN 980:2003 Graphical Symbols for Use in the Labelling of Medical Devices
EN 980:1996 Graphical Symbols for Use in the Labelling of Medical Devices
EN 980:1996/PRA2:1996 Graphical Symbols for Use in the Labelling of Medical Devices Amendment PRA2
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)

Comitato Elettrotecnico Italiano

CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
CEI UNI EN 980:2010 Simbols for use in the labelling of medical devices

German Institute for Standardization

DIN EN 980:2008-08 Symbols for use in the labelling of medical devices
DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN EN 15986 E:2009 Draft Document - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version prEN 15986:2009
DIN EN ISO 15223-1:2012-10 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
DIN EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN EN 980 E:2006 Draft Document - Symbols for use in the labelling of medical devices; German version prEN 980:2006
DIN EN ISO 15223-1:2020-04 Draft Document - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
DIN EN ISO 15223-1/A1:2019 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019
DIN EN ISO 15223-1:2013-02 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
DIN EN ISO 15223-1/A1:2019-11 Draft Document - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019
DIN EN ISO 15223-1:2020 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020

Standards Norway

NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
NS-EN 980:2003 Graphical symbols for use in the labelling of medical devices
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
NS-EN 980:2008 Symbols for use in the labelling of medical devices
NS-EN 980:1996 Graphical symbols for use in the labelling of medical devices
NS-EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)

Austrian Standards

ONORM EN 980-1996 Graphical symbols for use in the labelling of medical devices

Military Standards (MIL-STD)

MIL MIL-T-37202-1975 TAG, MEDICAL WARNING (NO S/S DOCUMENT)

COMMISSION FOR THE STANDARDS, METROLOGY AND QUALITY OF VIETNAM (STAMEQ)

TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied
TCVN 6916-1-2008 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied.Part 1: General requirements

Japanese Industrial Standards Committee (JISC)

JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

US-CFR-file

CFR 21-801.18-2013 Food and Drugs. Part801:Labeling. Section801.18:Format of dates provided on a medical device label.

Bureau of Indian Standards

IS/ISO 15223-1-2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part — General Requirements ( Second Revision )
IS/ISO 15223-2-2010 Medical devices —— Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied Part 2 Symbol Development, Selection and Validation

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
OS GSO 1827:2007 Labeling for industrial Products
OS GSO 1810:2007 Labeling for Chemical Products

American Society for Testing and Materials (ASTM)

ASTM F2211-02 Standard Classification for Tissue Engineered Medical Products (TEMPs)
ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
ASTM F2211-04 Standard Classification for Tissue Engineered Medical Products (TEMPs)
ASTM F2211-13(2021) Standard Classification for Tissue-Engineered Medical Products (TEMPs)
ASTM F2312-10 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F2727-09(2020) Standard Guide for Manufacturers for Labeling Headgear Products
ASTM F2312-24 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F2312-11 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F2312-04 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F2312-03 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM STP 1452-2004 Tissue Engineered Medical Products (TEMPs)
ASTM F2312-11(2020) Standard Terminology Relating to Tissue Engineered Medical Products

GCC Standardization Organization

GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
GSO ASTM F2211:2023 Standard Classification for Tissue-Engineered Medical Products (TEMPs)
BH GSO 1827:2024 Labeling for industrial Products

SCC

AAMI/ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AAMI/ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AAMI/ISO 15223-2000 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied - Includes Amendment 1, dated September 24, 2001
AAMI/ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation

South African Bureau of Standard

SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ASTM F2211:2023 Standard Classification for Tissue-Engineered Medical Products (TEMPs)
BH GSO ISO 15223-2:2017 Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation

IN-BIS

IS 10150-1981 Guidelines for Sterilization of Medical Products

US-FCR

FCR 40 CFR PART 211-2013 PRODUCT NOISE LABELING
FCR 40 CFR PART 211-2015 PRODUCT NOISE LABELING
FCR 40 CFR PART 211-2014 PRODUCT NOISE LABELING

GB-REG

REG 40 CFR PART 211-2011 PRODUCT NOISE LABELING

Magyar Szabványügyi Testület

MNOSZ 14678-1955 Stands for medical products (suspended)

Associação Brasileira de Normas Técnicas

ABNT NBR ISO 15223-1:2010 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1- General requirements