Brief Guide

1-1．Certification fees :

・Particulate respirator

Disposable particulate respirator (with exhaust valve)：¥230,500

Disposable particulate respirator (without exhaust valve)：¥230,500

Replaceable type particulate respirator ：¥230,500

・Gas respirator

Replaceable type gas respirator with particulate filtering function : ¥300,900

Replaceable type gas respirator without particulate filtering function: ¥260,900

Canister and cartridges with particulate filtering function: ¥283,800

Canister and cartridges without particulate filtering function: ¥243,800

・Powered air purifying respirators (PAPR)

Tight fitting type：¥639,100

Loose fitting type: ¥619,200

1-2．The estimated time for certification: From the submission of the application document to the notification of the certification test result：About two and a half months at normal condition. （If there is unsatisfactory situation on the applicant side and corrective action can’t be taken within the time limit, the verification process may stop and may not pass or end.）

1-3．Remarks for the preparation of the application document

 

1) Certification application documents (bound documents including drawings of the objective device, list of examination facilities and manufacturing facilities, inspection rules, test results conducted in advance, and others described by the Guidance document for applicating respiratory protective devices to the certification test by TIIS.)

2）Test results on the objective device should be those obtained by the applicant with the test methods in accordance with the Japanese standards of particulate respirators, gas respirators and of PAPRs.

3）All the documents filed in the application document must be written in Japanese.

4）Please make these documents according to the application guide.

1-4．Number of test samples to be submitted.(If you intend to apply for a variation of the same type of product in one application, please send the variation of completed respirator for identification. )
・Disposable particulate respirator with exhaust valve：12 pieces of completed respirator, 3 pairs of exhaust valve and exhaust valve seat which are separated from the filtering facepiece. 
・Disposable particulate respirator with no exhaust valve：12 pieces of completed respirator, 1 piece of completed respirator for storage.

・Replaceable type particulate respirator：5 sets of completely assembled respirator, 7 sets of replacing filters, 3 sets of exhaust valve and exhaust valve seat. 

・Gas respirator with particulate filtering function : 4 sets of completely assembled gas respirator, 20 sets of canister(s) or cartridge(s) (with particulate filter(s)), 3 pairs of exhaust valve and exhaust valve seat.

・Gas respirator mask with no particulate filtering function: 4 sets of completely assembled gas respirator, 13 sets of canister(s) and cartridge(s), 3 pairs of exhaust valve and exhaust valve seat.

・Canister(s) and cartridge(s) with particulate filtering function：1 set of completely assembled gas respirator with canister(s) or cartridge(s) with particulate filter(s) , 23 sets of canister(s) and cartridge(s) with particulate filter(s).

・Canister(s) and cartridge(s) with no particulate filtering function：1 set of completely assembled gas respirator, 15 sets of canister(s) or cartridge(s).

Powered air purifying respirators(PAPR) of tight fitting type：7 sets of completely assembled PAPR, 14 sets of spare filters, 3 sets of exhaust valve and exhaust valve seat.

Powered air purifying respirators (PAPR) of loose fitting type：6 sets of pieces completely assembled PAPR, 14 sets of spare filters.

1-5．On-site inspection at manufacturer’s factory: It is necessary to inspect the facilities for manufacturing and quality control system operated at the plant with which the type of the respirator submitted to the certification is manufactured. Thus inspection is executed at the first application of the product manufactured at the plant, and afterwards, the on-site inspection is executed when the partly change of the facilities of the plant is reported. TIIS staff will visit the plant and will examine whether the manufacturing and testing equipment are installed and managed with responsible organization in conformity with the requirements of the government standard of certification of machines and others.

・Fee of on-site inspection: ¥163,000 per day.

Additional payment for the staff’s allowance and actual expenses for transportation and accommodation are charged.

1-6．Current standards and test procedures etc ： The test procedures adopted for the type verification tests are not defined in JIS T8151 but in the government regulatory standards of particulate respirator, gas respirators, and PAPR enforced by the Industrial Safety and Health Act. Please refer to the following homepage.

＊Standard of particulate respirator at the homepage of Ministry of Health, Labor and Welfare (in Japanese)

https://www.mhlw.go.jp/web/t_doc?dataId=74041000&dataType=0&pageNo=1

＊Standard of gas respirator at the homepage of Ministry of Health, Labor and Welfare (in Japanese)

https://www.mhlw.go.jp/web/t_doc?dataId=74042100&dataType=0&pageNo=1

・Please contact us if you need these English version for those standards.

＊Standard of PAPR at the homepage of Ministry of Health, Labor and Welfare (in Japanese)

https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/koyou_roudou/roudoukijun/anzen/an-eihou/

・This is not translated into English, so please check in Japanese.

1-7．Necessary requirements for the applicant of type-specific certification of respirators with respect to the manufacturing and testing facilities equipped in the plant where the objective respirator is manufactured is described in the government standard of certification of machines and others (in Japanese). It is presented in the homepage of the Ministry of Health. Labour and Welfare at the following address.

https://www.mhlw.go.jp/web/t_doc?dataId=74072000&dataType=0&page

・This standard is not translated into English, so please check in Japanese or inquire.