|
1
|
SNI
16-4221-1996
|
|
Baby incubators (nursing)
|
|
|
|
2
|
SNI
16-4286-1996
|
|
Moved type phototherapy unit
|
|
|
|
3
|
SNI
16-4778-1998
|
|
Particular requirements for the safety of high frequency surgical equipment
|
|
|
|
4
|
SNI
16-4938-1998
|
|
Stainless steel implant plate
|
|
|
|
5
|
SNI
16-4939-1998
|
|
Electrocardiographs
|
|
|
|
6
|
SNI
16-4940.1-1998
|
|
Electrically powered medical suction equipment
|
|
|
|
7
|
SNI
16-4940.2-1998
|
|
Medical suction equipment powered from vacuum or pressure sources
|
|
|
|
8
|
SNI
16-4942-1998
|
|
Transport incubator
|
|
|
|
9
|
SNI
16-6073-1999
|
|
Extra corporeal blood circuit haemodialysers, haemofilters and haemoconcentrators
|
|
|
|
10
|
SNI
16-6071-1999
|
|
Haemodialysers, haemofilters and haemoconcentrators
|
|
|
|
11
|
SNI
04-6191.2.4-1999
|
|
Medical electrical equipment. Part 2.4: Particular requirements for the safety of cardiac
defibrillators and cardiac defibrillator - Monitors
|
|
|
|
12
|
SNI
16-6155-1999
|
|
Microwave therapy equipment
|
|
|
|
13
|
SNI
04-6284.2-2000
|
|
Medical electrical equipment. Part 2: Particular requirements for the safety of short-wave therapy
equipment
|
|
|
|
14
|
SNI
16-6362-2000
|
|
Endoscopic equipment
|
|
|
|
15
|
SNI
16-6355.1-2000
|
|
Steril, single-use intravascular catheters - General requirement
|
|
|
|
16
|
SNI
16-6355.2-2000
|
|
Sterile, single use intravascular catheters - Angiographic catheters
|
|
|
|
17
|
SNI
16-6355.3-2000
|
|
Steril, single-use intravascular catheters - Central venous catheters
|
|
|
|
18
|
SNI
16-6355.4-2000
|
|
Steril, single-use intravascular catheters - Ballon dilatation catheters
|
|
|
|
19
|
SNI
16-6355.5-2000
|
|
Steril, single-use intravascular catheters - Intravena catheters
|
|
|
|
20
|
SNI
16-6357-2000
|
|
Anaesthetic machines for use with human
|
|
|
|
21
|
SNI
16-6357.1-2001
|
|
Ventilated anaesthetic machines - Safety aspects
|
|
|
|
22
|
SNI
16-6360-2000
|
|
Pulse oximeters for medical use
|
|
|
|
23
|
SNI
16-6361-2000
|
|
Electroencephalographs
|
|
|
|
24
|
SNI
16-6631-2002
|
|
Oxygen monitors for monitoring patient bretahing mixtures - Safety requirements
|
|
|
|
25
|
SNI
16-6636-2002
|
|
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
|
|
|
|
26
|
SNI
16-6637-2002
|
|
Oxygen concentrators for medical use - Safety requirements
|
|
|
|
27
|
SNI
16-6638-2002
|
|
Therapeutic X-ray equipment operating in the range 10 kV to 1 MV - Safety
requirements
|
|
|
|
28
|
SNI
16-6639-2002
|
|
Diagnostic and therapeutic laser equipment - Safety requirements
|
|
|
|
29
|
SNI
ISO 8835-2-2008
|
|
Inhalational anaesthesia systems -- Part 2: Anaesthetic breathing systems
|
|
|
|
30
|
SNI
ISO 9918:2008
|
|
Safety requirement of capnometers use for human
|
|
|
|
31
|
SNI
ISO 10936-1:2008
|
|
Microscope for surgery - Part 1 : Specification and test method
|
|
|
|
32
|
SNI
ISO 10936-2-2008
|
|
Optic and optical instruments - Operation microscope - Part 2 : Light hazard from operation
microscopes used in ocular surgery
|
|
|
|
33
|
|
|
Ophthalmic optics -- Contact lenses -- Part 1: Vocabulary, classification system and
recommendations for labelling specifications
|
|
|
|
34
|
SNI
ISO 19001:2009
|
|
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro
diagnostic reagents for staining in biology
|
|
|
|
35
|
SNI
IEC 60601-2-5:2009
|
|
Medical electrical equipment - Part 2-5: Particular requirements for the safety ultrasonic
physiotherapy equipment
|
|
|
|
36
|
SNI
IEC 60601-2-7:2009
|
|
Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage
generators of diagnostic X-ray generators
|
|
|
|
37
|
SNI
IEC 60601-2-28:2009
|
|
Medical electrical equipment - part 2-28: Particular requirements for the safety of X-ray source
assemblies and X-ray tube assemblies for medical diagnosis
|
|
|
|
38
|
|
|
(Medical electrical equipment - Part 2-50: Particular requierements for basic safety and essential
performance of infant phototherapy equipment)
|
|
|
|
39
|
SNI
IEC 60601-1-2:2012
|
|
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic compability - Requirements and
testing
|
|
|
|
40
|
SNI
IEC 80601-2-35:2012
|
|
Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential
performance of heating devices using blankets, mats or mattresses and intended for heating in
medical use
|
|
|
|
41
|
SNI
ISO 9170-1:2012
|
|
Terminal units for medical gas pipeline systems - Part 1: Terminals unit for use with compressed
medical gases and vacuum
|
|
|
|
42
|
SNI
ISO 8536-4:2012
|
|
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity
feed
|
|
|
|
43
|
SNI
ISO 8638:2012
|
|
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters
|
|
|
|
44
|
SNI
ISO 15747:2012
|
|
Plastic containers for intravenous injections
|
|
|
|
45
|
SNI
ISO 22413:2012
|
|
Transfer sets for pharmaceutical preparations -- Requirements and test methods
|
|
|
|
46
|
SNI
ISO 80601-2-56:2012
|
|
Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential
performance of clinical thermometers for body temperature measurement
|
|
|
|
47
|
SNI
ISO 81060-2:2012
|
|
Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement
type
|
|
|
|
48
|
SNI
ISO 7885:2012
|
|
Dentistry -- Sterile injection needles for single use
|
|
|
|
49
|
SNI
ISO 8612:2012
|
|
Ophthalmics instruments-Tonometers
|
|
|
|
50
|
SNI
ISO 10651-4:2012
|
|
Lung ventilators - Part 4: Particular requirements for operator-powered
resuscitators
|
|
|
|
51
|
SNI
ISO 21987:2012
|
|
Ophthalmic optics-Mounted spectacle lenses
|
|
|
|
52
|
|
|
Medical electrical equipment - Part 2-21: Particular requirements for tha basic safety and
essential performance of infant radiant warme
|
|
|
|
53
|
|
|
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical
|
|
|
|
54
|
|
|
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment
|
|
|
|
55
|
|
|
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard:
Programmable electrical medical systems
|
|
|
|
56
|
|
|
High frequency surgical equipment - Operation and maintenance
|
|
|
|
57
|
|
|
Sharp injure protection - Requirement and test methods - sharps protection features for single-use
hypodermic needles, introducers for catheters and needles used for blood sampling
|
|
|
|
58
|
|
|
Medical devices - Symbol to be used with medical device labels, labeling and information to be
supplied - Part 2 : Symbol development, selection, validation
|
|
|
|
59
|
SNI
IEC 60513:2014
|
|
Fundamental aspects of safety standards for medical electrical equipment
|
|
|
|
60
|
SNI
IEC 60601-1:2014
|
|
Medical electrical equipment- Part 1: General requirements for basic safety and essential
performance
|
|
|
|
61
|
SNI
IEC 60601-1-1:2014
|
|
Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard:
Safety requirements for medical electrical systems
|
|
|
|
62
|
SNI
IEC 60601-2-19:2014
|
|
|
|
|
|
63
|
SNI
IEC 60601-2-20:2014
|
|
|
|
|
|
64
|
SNI
IEC 60601-2-51:2014
|
|
Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential
performance, of recording and analysing single channel and multichannel
electrocardiographs
|
|
|
|
65
|
SNI
IEC 60601-2-52:2014
|
|
|
|
|
|
66
|
SNI
IEC 62353:2014
|
|
Medical electrical equipment - Recurrent test and test after repair of medical electrical
equipment
|
|
|
|
67
|
SNI
IEC 80601-2-30:2014
|
|
|
|
|
|
68
|
SNI
IEC 60601-2-2:2014
|
|
Medical electrical equipment - Part 2-2: Particular requirement for the basic safety and essential
performance of high frequency surgical equipment and high frequency surgical
accessories
|
|
|
|
69
|
SNI
IEC 62354:2014
|
|
General testing Procedure for medical electrical equipment
|
|
|
|
70
|
SNI
IEC 62653:2014
|
|
Guideline for safe of medical equipment used for haemodialysis treatment
|
|
|
|
71
|
SNI
ISO 80601-2-13:2014
|
|
Medical electrical equipment - Part 2-13: Particular requirement for the safety and essential
performance of anaesthetic systems (workstation)
|
|
|
|
72
|
SNI
ISO 80601-2-61:2014
|
|
Medical electrical equipment - Part 2-61: Particular requirement for basic safety and essential
performance of pulse oximeter equipment
|
|
|
|
73
|
SNI
ISO 11135-1:2014
|
|
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
|
|
|
|
74
|
SNI
ISO 11607-2:2014
|
|
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming,
sealing and assembly processes
|
|
|
|
75
|
SNI
IEC 60601-2-47:2014
|
|
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and
essential performance of ambulatory electrocardiographic systems
|
|
|
|
76
|
SNI
IEC 80601-2-60:2014
|
|
Medical electrical equipment - Part 2 -60: Particular requirements for the basic safety and
essential performance of dental equipment
|
|
|
|
77
|
SNI
IEC/TR 60878:2014
|
|
Graphical symbols for electrical equipment in medical practice
|
|
|
|
78
|
|
|
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
|
|
|
|
79
|
|
|
Guidelines for administrative, medical and nursing staff concerned with the safe use of medical
electrical equipment and medical electrical systems
|
|
|
|
80
|
|
|
High frequency surgical equipment - Operation and maintenance
|
|
|
|
81
|
|
|
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and
essential performance of infusion pumps and controllers
|
|
|
|
82
|
|
|
Lung ventilators for medical use Particular requirements for basic safety and essential performance
- Part 5: Gas powered emergency resuscitators
|
|
|
|
83
|
|
|
Lung ventilators - Part 4: Particular requirements for operator-powered
resuscitators
|
|
|
|
84
|
|
|
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and
essential performance of electrocardiografic monitoring equipment
|
|
|
|
85
|
|
|
Anaesthetic and respiratory equipment - Nebulizing systems and components
|
|
|
|
86
|
SNI
IEC 60601-2-24:2016
|
|
Medical electrical equipment – Part 2-24: Particular requirements for basic safety and essential
performance of infusion pumps and controllers
|
|
|
|
87
|
SNI
IEC 60601-2-27:2016
|
|
Medical electrical equipment – Part 2-27: Particular requirements for basic safety and essential
performance of electrocadiographic monitoring equipments
|
|
|
|
88
|
SNI
IEC/TR 60930:2016
|
|
Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical
electrical equipment and medical electrical systems
|
|
|
|
89
|
SNI
IEC/TR 61289:2016
|
|
High frequency surgical equipment – Operation and maintenance
|
|
|
|
90
|
SNI
ISO 10651-4:2016
|
|
Lung ventilators - Part 4: Particular requirements for operator-powered
resuscitators
|
|
|
|
91
|
SNI
ISO 10651-5:2016
|
|
Lung ventilators for medical use — Particular requirements for basic safety and essential
performance — Part 5: Gas-powered emergency resuscitators
|
|
|
|
92
|
SNI
ISO 27427:2016
|
|
Anaesthetic and respiratory equipment – Nebulizing systems and components
|
|
|
