Safety : ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin

EMC : -

Performance : IEC 6009-4:2008 Syringes, needles and certain other medical equipment - Part 4: Syringes for use with power-driven syringe pumps

Local Standard

USA :
ISO 7886-4 Second Edition 2018-11 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
ISO 11040-4 Third edition 2015-04-01 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
ISO 7886-3 Second edition 2020-05 Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
21 CFR 880.5860 Piston syringe
21 CFR 878.4800 Manual surgical instrument for general use.

Europe:
EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN ISO 7886-2:2020(MAIN) Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)
EN ISO 7886-3:2020(MAIN) Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
EN ISO 8537:2016(MAIN) Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

China:
GB 9706.1: General requirements for safety of medical electrical equipment
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 15810-2001 - Sterile hypodermic Syringes for single use
GB/T 1962.2-2001 - The conical fittings with a 6%(Luer)taper for Syringes，needles and certain other medical equipment--Part 2:Lock fittings
GB 15810-2019 - Sterile Syringes for single use

Japan:
JIS T 0601-1: General requirements for safety of medical electrical equipment
JIS T 3201:1979 Glass syringes
JIS T 3210:2022 Sterile injection syringes
JIS T 3253:2012 Sterile single-use syringes, with or without needle, for insulin
JIS T 3254:2013 Single-use syringes for blood gas specimen collection

Korea:
KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
KS P ISO7886-1: Disposable Sterile Hypodermic Syringes ─ Part 1: Manual Syringes
KS P ISO7886-2: Disposable Sterile Hypodermic Syringes ─ Part 2: Syringes for Use with Motorized Syringe Pumps
KS P ISO7886-3:Disposable Sterile Hypodermic Syringes—Part 3: Automated Inert Syringe for Fixed-Dose Immunization
KS P ISO7886-4: Disposable Sterile Hypodermic Syringes ─ Part 4: Syringes with Reusability Proof

Taiwan:
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 14774 - Disposable hypodermic syringes for single use
CNS 14611 - Auto-disable syringes for fixed-dose immunization
CNS 14775 - Sterile hypodermic syringes for single use

Brasil:
ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ABNT NBR ISO 7886-1:2020-01-24 Sterile hypodermic syringes for single use Part 1: Syringes for manual use
ABNT NBR ISO 7886-2:2021-11-19 Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
ABNT NBR ISO 8537:2020-05-05 Sterile single-use syringes, with or without needle, for insulin
ABNT NBRISO594-2 DE 08/2003 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings

Mexico:
NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NOM-005-SSA1-1993 Goods and services. Medical devices. Syringes for single use. Safety and efficacy specifications and test methods

Argentina:
IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IRAM 9032 Sterile hypodermic syringes for single use. Syringes for manual use. (ISO 7886-1:2017, IDT)
IRAM 27063 Dental materials. Syringes for cartridges.

Australia:
AS 1094.1-2004 AMDT 1 Sterile hypodermic syringes for single use, Part 1: Syringes for manual use

South Africa:
SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SANS 8537:2022 (Ed. 1.00):Sterile single-use syringes, with or without needle, for insulin
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 1124-2:2020 (Ed. 4.01):Syringes and needles (sterile-packed for single use) Part 2: Syringes

Saudi Arabia:
SASO IEC 60601-1:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SASO 2549:2019: Syringes for Medical Use
SASO 2534:2018: Sterile Hypodermic Syringes for Single Use
SASO 2881:2019: Needle-based Injection Systems for Medical Use
GSO ISO 7886-1:2021: Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

EAEU: