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Important ISO Standards For Medical Devices
Important ISO Standards For Medical Devices
Devices
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13. **ISO/TR 24971:** Guidance on applying ISO 14971 for medical devices.
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15. **ISO 16571:** Systems for evacuation of plume from medical devices.
31. **ISO 11117:** Design, construction, and tests for gas cylinders.
37. **ISO 14117:** EMC test protocols for implantable cardiac devices.
42. **ISO 22610:** Test method for resistance to wet bacterial penetration.
44. **ISO 23747:** Peak expiratory flow meters for pulmonary function
assessment.
46. **ISO 14708-1:** General requirements for safety of implants for surgery.
59. **ISO 11040-8:** Requirements and test methods for finished pre-filled
syringes.
69. **ISO 9626:** Stainless steel needle tubing for medical devices.