Needles

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

EMC : -

Performance : IEC 6009-6:2015 Syringes, needles and certain other medical equipment - Part 6: Needle-free injectors for medical use ISO 11608-5:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
ISO 11608-4:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics

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 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

Mexico:
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

Argentina:
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.