CIRCULAR

PROMULGATING THE NATIONAL TECHNICAL REGULATION ON RESPIRATORY PROTECTIVE DEVICES – PARTICLE FILTERS

Pursuant to the Government's Decree No. 186/2007/ND-CP dated December 25, 2007, defining the functions, duties, power and organizational structure of the Ministry of Labor-Invalids and Social Affairs;

Pursuant to the Government’s Decree No. 127/2007/ND-CP, of August 01, 2007, detailing implementation of a number of Articles of Law on Standards and Technical Regulations;

Pursuant to the Government’s Decree No. 132/2008/ND-CP, of December 31, 2008, detailing implementation of a number of Articles of Law on product and goods quality;

After having the appraisal opinion of the Ministry of Science and Technology at the official dispatch No. 3421/BKHCN-TDC dated December 30, 2011, the Minister of Labor-Invalids and Social Affairs, promulgating the national technical regulations on respiratory protective devices – particle filters as follows:

Article 1. To promulgate together with this Circular the national technical regulation on respiratory protective devices – particle filters.

Sign: QCVN 08:2012/BLDTBXH  

Article 2. The national technical regulation on respiratory protective devices – particle filters takes effect after 06 months from the day of signing this Circular. 

Article 3. Ministries, ministerial-level agencies, Governmental agencies, the provincial People’s Committees, and relevant organizations and individuals shall be responsible for implementation.

QCVN 08: 2012/BLDTBXH

NATIONAL TECHNICAL REGULATION ON RESPIRATORY PROTECTIVE DEVICES – PARTICLE FILTERS

Foreword

QCVN 08: 2012/BLDTBXH was composed by the Group of drafting national technical regulation on respiratory protective devices – particle filters, then the Department of Labor safety submitted it for approval, the Ministry of Science and Technology appraised it, and the Ministry of Labor - Invalids and Social Affairs promulgated it together with the Circular No. 07/2012/TT-BLDTBXH.

NATIONAL TECHNICAL REGULATION

ON RESPIRATORY PROTECTIVE DEVICES – PARTICLE FILTERS

1. GENERAL PROVISIONS

1.1. Scope of adjustment

This Regulation prescribes the safety requirements applicable to respiratory protective devices – Particle filters which are components for filtering particle according to classification at section 5 of European Standard (EN) 143:2000 (E) Respiratory protective devices – Particle filters –Requirements testing, marking.

1.2. Subjects of application

1.2.1. This regulation applies to organizations and individuals producing, importing, circulating and using the respiratory protective devices – particle filters.

1.2.2. Organizations of examining the product and goods quality, state management agencies, and relevant organizations and individuals.

1.3. Interpretation of terms

In this Regulation, it uses terms of the European Standard as follows:

1.3.1. EN 132:1999: Respiratory protective devices- Definition of terms and pictograms.

1.3.2. EN 134:1998 Respiratory protective devices – Nomenclature of components

In addition to, to supplement:

1.3.3. Respiratory protective devices – particle filters which are able to reuse : are respiratory protective devices – particle filters designed to use for more than one work shift.

2. TECHNICAL REGULATION

2.1. Respiratory protective devices – particle filters must satisfy requirements defined in the European Standard (EN) 143:2000 (E) Respiratory protective devices – particle filters – Requirements, testing, marking.

2.2. In case where the European Standard stated above have amendments or supplementations, the last provisions shall be applied.

3. QUALITY MANAGEMENT

3.1. Respiratory protective devices – particle filters which are produced domestically

3.1.1. Respiratory protective devices – particle filters produced domestically must be announced the regulation conformity in accordance with section 2 of this Regulation on the basis of assessment of conformity of the certificate organizations which are appointed by the Ministry of Labor - Invalids and Social Affairs. 

The certification of regulation conformity is performed according to method of testing typical sample and assessing the process of production and supervision through testing samples taken at production place in association with assessment of the production process (method 3 –Annex II of Regulation on certification of standard conformity, regulation conformity and announcement of standard conformity, announcement of regulation conformity promulgated together with the Decision No. 24/2007/QD-BKHCN dated September 28, 2007 of the Minister of Science and Technology).

3.1.2. Respiratory protective devices – particle filters produced domestically must be stuck seal of regulation conformity, and labeled according to the European Standard (EN) 143:2000 (E) Respiratory protective devices –Particle filters –Requirements testing, marking, before put them into circulation on market. The labeling of goods must comply with the currency provisions of Vietnamese Law.

3.2. Import respiratory protective devices – particle filters

3.2.1. Import respiratory protective devices – particle filters must be certified the regulation conformity in accordance with provisions in section 2 of this Regulation.

3.2.2. The Ministry of Labor - Invalids and Social Affairs shall appoint (or recognize) domestic and foreign verification organizations or certificate organizations to perform the certification of regulation conformity.

3.2.3. The certification of regulation conformity is performed according to method of testing, assessing batch of products or goods (method 7 in “Regulation on certification of standard conformity, certification of regulation conformity and announcement of standard conformity, announcement of regulation conformity” promulgated together with the Decision No. 24/2007/QD-BKHCN dated September 28, 2007 of the Minister of Science and Technology).

3.2.4. Import respiratory protective devices – particle filters must be stuck seal of regulation conformity, and labeled according to the European Standard (EN) 143:2000 (E) Respiratory protective devices –Particle filters –Requirements testing, marking, before put them into circulation on market. The labeling of goods must comply with the currency provisions of Vietnamese Law.

3.3. Respiratory protective devices – particle filters circulating on market

3.3.1. Respiratory protective devices – particle filters circulating on market must have seal of regulation conformity, and be labeled according to the European Standard (EN) 143:2000 (E) Respiratory protective devices –Particle filters –Requirements testing, marking. The labeling of goods must comply with the currency provisions of Vietnamese Law.

3.3.2. In necessary case, the competent state management agencies may conduct examination of quality for respiratory protective devices – particle filters circulating on market same as respiratory protective devices – particle filters produced domestically or imported.

3.4. Management of respiratory protective devices – particle filters during usage

3.4.1. To store and preserve respiratory protective devices – particle filters in accordance with guide of producers.

3.4.2. To use respiratory protective devices – particle filters for proper purpose, properly with function of each device.

3.4.3. Specially to pay attention to warnings on being able to cause safety loss during usage. Not reuse respiratory protective devices – particle filters for twice if producers prescribe for use of once only, not use respiratory protective devices – particle filters which were expired for usage.

4. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

4.1. Organizations and individuals producing, importing, exporting, circulating and using the respiratory protective devices – particle filters are responsible for complying with provisions in this Regulation.

4.2. This Regulation is grounds for state management agencies of product and goods quality, agencies of inspection of product and goods quality to conduct inspection, and also is grounds for conformity certificate organizations to conduct certification of regulation conformity for respiratory protective devices – particle filters.

5. ORGANIZATION OF IMPLEMENTATION

5.1. The Department of Labor safety shall coordinate with the relevant functional agencies in guiding and organizing implementation of this Regulation.

5.2. The local labor state management agencies shall inspect and examine implementation of provisions of this Regulation.

5.3. Any problems arising in the course of implementation should be promptly reported to the Ministry of Labor - Invalids and Social Affairs for consideration and settlement.