Safety : ISO 11608-6:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems

EMC : - 

현지 표준

미국:

21CFR878.4400 GENERAL AND PLASTIC SURGERY DEVICES: Surgical Devices
ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles
ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
ISO 23908 First edition 2011-06-11 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
ASTM F1874-98 (Reapproved 2011) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
ASTM F 1840:2010 Standard Terminology for Surgical Suture Needles
ASTM F 3014:2014 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures

유럽:
EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN ISO 11608-2:2022(MAIN) Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
EN ISO 11608-5:2023(MAIN) Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
EN ISO 11608-4:2022(MAIN) Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)

중국:
GB 9706.1: General requirements for safety of medical electrical equipment
GB 2024-2016 - Acupuncture Needles
GB 15811-2016 - Sterile hypodermic Needles for single use
GB/T 1962.1-2015 - Conical fittings with a 6%(Luer) taper for syringes,Needles and certain other medical equipment—Part 1: General requirement
GB 18671-2009 - Intravenous Needles for single use

일본:
JIS T 0601-1: General requirements for safety of medical electrical equipment
JIS T 3101:1979 Injection needles
JIS T 3102:2021 Surgical needles
JIS T 3209:2022 Sterile injection needles
JIS T 3220:2011 Sterile blood collection needles
JIS T 3226-2:2015 Needle-based injection systems for medical use -- Part 2: Needles -- Requirements and test methods
JIS T 3228:2018 Biopsy needles for single use

한국:
KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
KS P 3007: Sterile acupuncture needles for single use
KS P ISO7864: Disposable Sterile Hypodermic Needles—Requirements and Test Methods

대만:
CNS 60601:2015 Medical electrical equipment - Part 1: General requirements for safety
CNS 12974 Conical Fittings with a 6% (Luer) for Syringes, Needles and Certain Other Medical Equipment- Part 1:General Requirement
CNS 11963:2002 - Hypodermic needles for single use
CNS 13963:2003 - Acupuncture needles for single use
CNS 10716:2006 - Sterilized surgical stainless steel needles for single use

브라질:
ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ABNT NBR ISO 6009:2020-05-22 Hypodermic needles for single use - Colour coding for identification
ABNT NBR ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods
ABNT NBRISO594-2 DE 08/2003 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ABNT NBRISO594-1 DE 08/2003 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements

멕시코:
NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NOM-110-SSA1-1994 Goods and services. Medical devices. Needles for single use. Safety and efficacy specifications and test methods

아르헨티나:
IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IRAM 9017 Sterile hypodermic needles for single use.

오스트레일리아:
AS ISO 17218:2014 Sterile acupuncture needles for single use

남아프리카 공화국:
SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SANS 1124-3:2020 (Ed. 1.01): Syringes and needles (sterile-packed for single use) Part 3: Syringes with a re-use prevention feature
SANS 3096:2005 (Ed. 1.00):Rolling bearings - Needle rollers - Dimensions and tolerances
SANS 1918:2011 (Ed. 1.01): Needleless connectors (sterile-packed for single patient use)

사우디아라비아:
SASO IEC 60601-1:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GSO ISO 7864:2021 Sterile Hypodermic Needles For Single Use — Requirements And Test Methods
GSO ISO 17218:2021 Sterile Acupuncture Needles For Single Use
GSO ISO 18746:2021 Traditional Chinese Medicine — Sterile Intradermal Acupuncture Needles For Single Use
GSO ISO 11608-2:2013 Needle-Based Injection Systems For Medical Use -- Requirements And Test Methods -- Part 2: Needles

EAEU - 유라시아 경제 연합:
GOST R IEC 60601-1:2017 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GOST 25377-2015 Needles for injections for repeated use. Specification
GOST ISO 7864-2011 Sterile hypodermic needles for single use
GOST 25981-83 Surgical needles. General specifications
GOST 26641-85 Atraumatic needles. General technical requirements and test methods