Important ISO Standards For Medical

Devices
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1. **ISO 13485:** Quality management systems for regulatory compliance.

2. **ISO 14971:** Application of risk management to medical devices.

3. **IEC 62304:** Medical device software life cycle processes.

4. **ISO 62366-1:** Usability engineering application to medical devices.

5. **ISO 11135:** Requirements for ethylene oxide sterilization.

6. **ISO 15223-1:** Symbols for information supplied by the manufacturer.

7. **ISO 80369-1:** Small-bore connectors for healthcare applications.

8. **ISO 11607-1:** Packaging requirements for terminally sterilized devices.

9. **ISO 11607-2:** Validation requirements for packaging processes.

10. **ISO 11137-1:** Radiation sterilization process requirements.

11. **ISO 14155:** Good clinical practice for clinical investigations.

12. **ISO 19001:** In vitro diagnostic devices information requirements.

13. **ISO/TR 24971:** Guidance on applying ISO 14971 for medical devices.
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14. **ISO 11737-2:** Microbiological methods for sterility tests.

15. **ISO 16571:** Systems for evacuation of plume from medical devices.

16. **ISO 20916:** Clinical performance studies for in vitro diagnostic

devices.

17. **IEC 80001-1:** Safety, effectiveness, and security for connected

medical devices.

18. **IEC/TR 80002-1:** Guidance on applying ISO 14971 to medical device

software.

19. **IEC/TR 80002-2:** Validation of software for medical device quality

systems.

20. **IEC/TR 80002-3:** Process reference model for medical device

software life cycle.

21. **ISO 10993-1:** Biological evaluation with risk management.

22. **ISO 10993-2:** Animal welfare requirements for biological evaluation.

23. **ISO 10993-4:** Selection of tests for blood interactions.

24. **ISO 10993-5:** In vitro cytotoxicity tests for biological evaluation.

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25. **ISO 27186:** Four-pole connector system for implantable cardiac

devices.

26. **ISO 15194:** Measurement of quantities in biological samples.

27. **ISO 15883-1:** General requirements for washer disinfectors.

28. **ISO 15883-2:** Requirements for thermal disinfection in

washer-disinfectors.

29. **ISO 15883-5:** Performance requirements for washer disinfectors.

30. **ISO 9626:** Requirements for stainless steel needle tubing.

31. **ISO 11117:** Design, construction, and tests for gas cylinders.

32. **ISO 16142-1:** Essential principles of safety and performance for

non-IVD devices.

33. **ISO 16142-2:** Essential principles for IVD devices.

34. **ISO 17664-1:** Information for processing critical and semi-critical

medical devices.

35. **ISO 17664-2:** Information for processing non-critical medical devices.

36. **ISO 12052:** Digital imaging and communication in medicine (DICOM).

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37. **ISO 14117:** EMC test protocols for implantable cardiac devices.

38. **ISO 19223:** Vocabulary and semantics for lung ventilators.

39. **ISO/IEEE 11073-10101:** Device interoperability for point-of-care

medical device communication.

40. **ISO 13482:** Safety requirements for personal care robots.

41. **ISO 18113-1:** Information supplied by the manufacturer for in vitro

diagnostic devices.

42. **ISO 22610:** Test method for resistance to wet bacterial penetration.

43. **ISO 23640:** Evaluation of stability of in vitro diagnostic reagents.

44. **ISO 23747:** Peak expiratory flow meters for pulmonary function
assessment.

45. **ISO 28620:** Nonelectrically driven portable infusion devices.

46. **ISO 14708-1:** General requirements for safety of implants for surgery.

47. **ISO 14708-2:** Requirements for cardiac pacemakers.

48. **ISO 14708-5:** Requirements for circulatory support devices.

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49. **ISO 20417:** Information to be supplied by the medical device

manufacturer.

50. **ISO 22442-1:** Risk management application for medical devices

utilizing animal tissues.

51. **ISO 8871-1:** Requirements for elastomeric parts in pharmaceutical

use.

52. **ISO 8871-2:** Identification and characterization of elastomeric parts.

53. **ISO 8871-3:** Determination of released-particle count for elastomeric

parts.

54. **ISO 8871-4:** Biological requirements and test methods for

elastomeric parts.

55. **ISO 8871-5:** Functional requirements and testing for elastomeric

parts.

56. **ISO 11040-4:** Requirements for glass barrels in pre-fillable syringes.

57. **ISO 11040-5:** Requirements for plunger stoppers in pre-filled syringes.

58. **ISO 11040-7:** Requirements for packaging systems in pre-fillable

syringes.
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59. **ISO 11040-8:** Requirements and test methods for finished pre-filled
syringes.

60. **ISO 4802-1:** Determination of hydrolytic resistance of glass

containers.

61. **ISO 4802-2:** Determination of hydrolytic resistance by flame

spectrometry.

62. **ISO 15378:** Particular requirements for primary packaging materials.

63. **ISO 10993-7:** Residuals from ethylene oxide sterilization.

64. **ISO 13485:** Quality management systems for regulatory purposes.

65. **ISO 7886-1:** Sterile hypodermic syringes for single use.

66. **ISO 14971:** Application of risk management to medical devices.

67. **ISO 720:** Hydrolytic resistance of glass grains at 121°C.

68. **ISO 7864:** Sterile hypodermic needles for single use.

69. **ISO 9626:** Stainless steel needle tubing for medical devices.

70. **ISO 10993-4:** Selection of tests for interactions with blood.

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71. **ISO 10993-5:** Tests for in vitro cytotoxicity.

72. **ISO 10993-6:** Tests for local effects after implantation.

73. **ISO 10993-10:** Tests for irritation and skin sensitization.

74. **ISO 10993-11:** Test for systemic effects.