NIOSH 인증 안내(Respirators 호흡기 마스크)

[은율아버지]

Schedule 84A에서 Respirators에 대해 다음과 같이 규정합니다.

미립자 여과 호흡기( Air-Purifying Filtering Facepiece Respirator);

• N, R 또는 P 분류의 필터가 있는 조합된 화학 카트리지 / 필터의 호흡 보호구;

• 조합 N, R 또는 P 분류의 필터 / 급기 호흡기 시스템;

• 화학 카트리지 / 급기 호흡 보호구 시스템과 조합된 N, R 또는 P 분류의 필터.

미국법규정 42 CFR Section 84.2에서

승인(Approval )의 의미는

1) 개별 호흡기 또는 조합된 호흡기가 이 규정의 최소 요구 사항을 충족했으며,

2) 신청자가 호흡기, 호흡기 용기 또는 호흡기 용기에 승인 라벨을 사용하고 부착 할 권한이 있음을

명시하는 해당기관에서 발행한 인증서 또는 공식적 문서를 의미합니다.

새로운 NIOSH 기준에 따라 호흡기용 필터재료는 약 0.3 um의 공기 역학적 직경을 가진 입자의 침투에 관련하여 분당 85L의 유속으로 시험합니다.

9개의 각 종류별 등급에 대해 아래와 같은 특성으로 구분되는 필터가 지정됩니다.

N series -- Not resistant to oil

R series -- Resistant to oil

P series -- oil Proof

42 CFR Part 84 Subpart K 참조

Facepiece Respirators
Designation	Minimum Efficiency	Test Agent	Maximum Test Challenge Loading	Remarks
N100	99.97%	NaCl sodium chloride	200 mg filter loading	mildly degrading aerosol
N99	99%	NaCl	200 mg filter loading	mildly degrading aerosol
N95	95%	NaCl	200 mg filter loading	mildly degrading aerosol
R100	99.97%	DOP dioctylphthalate	200 mg filter loading	highly degrading aerosol
R99	99%	DOP	200 mg filter loading	highly degrading aerosol
R95	95%	DOP	200 mg filter loading	highly degrading aerosol
P100	99.97%	DOP	Maximum filter degradation	highly degrading aerosol
P99	99%	DOP	Maximum filter degradation	highly degrading aerosol
P95	95%	DOP	Maximum filter degradation	highly degrading aerosol

1. NIOSH 인증신청 절차에서는 제조사는 3 자리 제조업체 코드를 신청합니다. 그 다음 회사 품질 보증 (QA) 매뉴얼과 함께 한 종류의 호흡기 제품에 대한 초기 신청서를 제출하게 됩니다.

- 최초 인증신청에서는 다수의 제품신청을 할 수 없습니다.

2. 신청회사는 제품이 규격에 적합함을 입증하기 위해 사전에 제품의 적합성을 평가한 시험결과와 신청시 필수 문서를 작성하여 NIOSH 에 인증신청서를 제출합니다.

- NIOSH 및 FDA의 각 규격별 지정 시험소에서 Pre-certification을 위한 시험을 수행합니다.

- NIOSH 인증신청 필요문서

1) Application Form (지정양식)

2) Pretest Data (지정 시험결과)

3) Drawings

4) Assembly Matrix

5) Draft approval labels

6) QA Manual

7) Product Quality Control Plan (PQP)

8) Fees

9) User Instructions

3. NIOSH 평가 수행

- 현장평가(Site Audit) 일수 참조

- 평가 점검표

4. NIOSH 승인 또는 거부 결정

- Approval or Denial Letters

- Cleared Letter for CAR etc.

5. NIOSH 및 MSHA 통합인증회사는 매년, 그리고 NIOSH 인증회사에게는 2년마다 현장심사를 받게 됩니다.

- 아래 인증(승인) 비용 참조

Respirator Certification (Approval) Fee Schedule A—Annual (Fixed) Fees
Fee Type	Legal Citation	Amount	Due Date
Maintenance of Product Performance (Product Audit)	42 CFR §84.20(b)(5)	•Annual fee: $761 per each approval holder •Variable fee: as billed by NIOSH based on therespirators chosen to be tested each year.	October 30 of applicable year.
Records Maintenance	42 CFR §84.20(b)(1)	$50 per every listed1 approval on file with NIOSH on July 1st of each year.	October 30 of applicable year.
Quality Assurance Maintenance (Site Audit)	42 CFR §84.20(b)(4)	•Annual fee: $3,000 per every manufacturingsite registered with NIOSH. •Variable fee:2 ▫1 day domestic audit - $2,500 per site. ▫2 day domestic audit - $5,000 per site. ▫1 day international audit - $7,500 per site. ▫2 day international audit - $10,000 per site.	October 30 of applicable year.
Maintenance of Testing and Approval Facilities	42 CFR §84.20(b)(2)	$34 per every listed1 approval on file with NIOSH on July 1st of each applicable year.	October 30 of applicable year.
Maintenance of Test Equipment	42 CFR §84.20(b)(2)	$36 per every active3 approval on file with NIOSH on July 1st of each applicable year.	October 30 of applicable year.
1.“Listed” approvals include all active and obsolete approvals. The Certified Equipment List (CEL) reflects the current listed approvals maintained by NIOSH. 2.Applies to design as well as manufacturing sites. 3.Does not include obsolete

NIOSH 인증신청에 요구되는 문서의 작성법 필수 참조할 것(문서내용, 문서작성법, 문서명칭부여방법, 문서개정표기법, 파일형태, 문서저장매체 등에 대하여 규정하고 있으니 필수적으로 규정을 준수하는 문서를 지정된 매체에 저장하여 발송하여야 합니다. (USB 저장매체 규정 참조)

1) Application Form

2) Pretest Data

3) Drawings

4) Assembly Matrix

5) Draft approval labels

6) QA Manual

7) Product Quality Control Plan (PQP)

8) Fees

9) User Instructions

a) If “zipped” files are submitted, provide the individual filename, description, and program for each working file contained in the zipped file.

b) If there is more than one User Instructions or assembly matrix, list each in the assembly matrix by name.

c) If NIOSH has requested replacement files, give the replacement files the same name as the original files.

d) Send replacement files only at the request of NIOSH, and send the replacement files directly to the NIOSH employee requesting the files. The requestor is responsible for having the corrected files posted to your project.

e) NIOSH will only accept replacement or new files that have been requested by NIOSH.

f)If FDA surgical mask clearance has been received, then the FDA 510K documentation must be included with the application, including the K number.

g) NIOSH will only accept single documents under a single filename.

h) Multiple documents under a single filename will not be accepted and the application may be denied.

아래는 시험항목입니다.

이들 시험항목은 제품의 종류 및 분류에 따라 적용을 검토하여야 합니다.

Respirator Tests for an Air-Purifying Filtering Facepiece Respirator

Item	Respirator Type	*NIOSH Test #	Title	Total Materials Needed
5a	Air-Purifying Filtering Facepiece 42 CFR 84 Particulate	TEB-APR-STP-0003	Determination of Exhalation Resistance.	3 exhalation valve assemblies (if present) 26 Filtering facepieces for each type.
		TEB-APR-STP-0004	Determination of Exhalation Valve Leakage.
		TEB-APR-STP-0007	Determination of Inhalation Resistance.
		TEB-APR-STP-0051	Determination of Particulate Filter Efficiency Level for P100 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
		TEB-APR-STP-0052	Determination of Particulate Filter Efficiency Level for P99 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
		TEB-APR-STP-0053	Determination of Particulate Filter Efficiency Level for P95 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
		TEB-APR-STP-0054	Determination of Particulate Filter Efficiency Level for R100 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
		TEB-APR-STP-0055	Determination of Particulate Filter Efficiency Level for R99 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
		TEB-APR-STP-0056	Determination of Particulate Filter Efficiency Level for R95 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
		TEB-APR-STP-0057	Determination of Particulate Filter Efficiency Level for N100 Series Filters Against Solid Particulates for Non-Powered Air-Purifying Respirators.
		TEB-APR-STP-0058	Determination of Particulate Filter Efficiency Level for N99 Series Filters Against Solid Particulates for Non-Powered Air-Purifying Respirators.
		TEB-APR-STP-0059	Determination of Particulate Filter Efficiency Level for N95 Series Filters Against Solid Particulates for Non-Powered Air-Purifying Respirators.
*Actual test selected may vary depending on design and intended use. *0005 and 0067 fit testing is not performed on Filtering Facepiece Respirators except where in the view of NIOSH the respirator suspension is a novel design. Novel designs require this testing to verify the respirator performance. NIOSH can assign additional testing based on review and determination for additional tests. Refer to 42 CFR 84.63(d).

적합평 평가시에 샘플의 수량은 아래 기준에 따릅니다. (기준에 따른 적합성 평가 대상의 샘플 수량)

Acceptable Quality Level (AQL)

Defect Classification	AQL 1,2
Major A	1.0
Major B	2.5
Minor	4.0

Inspection Level

Procedure	Minimum Inspection Level
Normal	Destructive1
MIL-STD-414	IV	I
ANSI/ASQ Z1.9-2003	II	S-3
MIL-STD-105D	II	S-2
MIL-STD-105E	II	S-2
ANSI/ASQ Z1.4-2003	II	S-2 [출처] NIOSH 인증 안내(Respirators 호흡기 마스크)|작성자 AP Network7

NIOSH 인증 안내.pdf