G/TBT/N/KWT/540  
15 April 2020  
(20-2899) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  THE STATE OF KUWAIT   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Public Authority for Industry (PAI)  
Kuwait Standard & Metrology Department (KUWSMD)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notific ation shall be indicated if different from above:   
Public Authority for Industry (PAI)  
P.O.Box:4690 Safat  
13047 Kuwait  
Code: 65451 Kuwait  
Tel.:(+965) 25302630  
Fax +965) 25302625  
E-mail: Enquiry_point@pai.gov. kw  
Website: http://www.pai.gov.kw  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  All 
products fall under scope of ISO 10993:2018 "Biological evaluation of medical devices — 
Part 1: Evaluation and testing within a risk management process"   (ICS 11.100.20); 
Biological evaluation of medical devices (ICS 11.100.20)  
5. Title, number of pages and language(s) of the notified document:  Biological 
evaluation of medical devices — Part 1: Evaluation and testing within a risk management 
process (41 page(s), in English)  
6. Description of cont ent: This document specifies:  
— the general principles governing the biological evaluation of medical devices within a 
risk management process;  
— the general categorization of medical devices based on the nature and duration of their 
contact with the body;  
— the evaluation of existing relevant data from all sources;  
— the identification of gaps in the available data set on the basis of a risk analysis;  
— the identification of additional data sets necessary to analyse the biological safety of 
the medica l device;  
— the assessment of the biological safety of the medical device.  G/TBT/N/KWT/540  
 
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  This document applies to evaluation of materials and medical devices that are expected 
to have direct or indirect contact with:  
— the patient's body during intended use;  
— the user' s body, if the medical device is intended for protection (e.g., surgical gloves, 
masks and others).  
This document is applicable to biological evaluation of all types of medical devices 
including active, non -active, implantable and non -implantable medical d evices.  
This document also gives guidelines for the assessment of biological hazards arising from:  
— risks, such as changes to the medical device over time, as a part of the overall biological 
safety assessment;  
— breakage of a medical device or medical de vice component which exposes body tissue 
to new or novel materials.  
Other parts of ISO 10993 cover specific aspects of biological assessments and related 
tests. Devicespecific or product standards address mechanical testing.  
This document excludes hazards related to bacteria, moulds, yeasts, viruses, 
transmissible spongiform encephalopathy (TSE) agents and other pathogens.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Environment and consumer protection; Consumer information, labelling; 
Protection of human health or safety; Protection of the environment  
8. Relevant documents:   
NA. This documents was adopted by permission of ISO Standards.  
9. Proposed date of adoption:  60 days from date of publication but it will be implemented 
in one day after approved by Kuwait ministry of commerce and industry due to corona 
virus (COVID -19) situation.  
Proposed date of entry into force:  180 days but due to urgent situation of  corona virus 
(COVID -19) it will be implemented in 7 days from date of publication of approved version 
by Kuwait ministry of commerce and industry, in line with health precautions related to 
dealing and limiting the spread of corona virus (COVID -19). 
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
ISO. This document was adopted by State of Kuwait under license from International 
Standards Organization.  
 
Public Authority for Industry (PAI)  
P.O.Box:4690 Safat  
13047 Kuwait  
Code: 65451 Kuwait  
Tel.:(+965) 25302630  
Fax
 +965) 25302625  
E-mail:mailto: Enquiry_point@pai.gov.kw   
Website: http://www.pai.gov.kw