G/TBT/N/KWT/546  
15 April 2020  
(20-2932) 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 11737 -1:2018 "Sterilization of health care products — 
Microbiological methods —Part 1: Determination of a  population of microorganisms on 
products (ICS 11.080.01; 07.100.10); Sterilization and disinfection in general (ICS 
11.080.01)  
5. Title, number of pages and language(s) of the notified document:  Sterilization of 
health care products — Microbiological met hods —Part 1: Determination of a population 
of microorganisms on products ) (48 page(s), in English)  
6. Description of content:  Specifies requirements and provides guidance on the 
enumeration and microbial characterization of the population of viable micr oorganisms 
on or in a health care product, component, raw material or package.  
NOTE 1 The nature and extent of microbial characterization is dependent on the intended 
use of bioburden data.  
NOTE 2 See Annex A for guidance on Clauses 1  to 9. 
This document does not apply to the enumeration or identification of viral, prion or 
protozoan contaminants. This includes the removal and detection of the causative agents 
of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and 
Creutzfeldt -Jakob disease.  G/TBT/N/KWT/546  
 
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  NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442 -3, ICH 
Q5A(R1) and ISO 13022.  
This document does not apply to the microbiological monitoring of the environment in 
which health care products are manufact ured. 
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 document is provided by 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) situ ation.  
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 precaut ions 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 membership in International 
Standards Organization (ISO).  
 
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