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Syringes

Syringes
Syringes

Syringes

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

ISO 7886-2:2020 Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps
ISO 7886-3:2020 Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization

Local Standard

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.

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