PPE Testing in Pakistan: EU 2016/425 Compliance

PPE must meet the Annex II safety requirements, directly or through harmonised standards

Regulation (EU) 2016/425 sets the design, manufacture and marketing rules for personal protective equipment across the EU, replacing Directive 89/686/EEC, and it has applied since 21 April 2018 (European Commission). Under it, a manufacturer must meet the essential health and safety requirements in Annex II.

That can be done directly. Harmonised European standards are the other route. A harmonised standard confers presumption of conformity with the requirements it covers.

A product's category depends on the highest risk it protects against

The regulation classifies PPE by risk under Article 18 and Annex I. Where a product protects against more than one risk, it takes the category of the highest risk it addresses (European Commission).

Category I covers minimal risk only, and the Annex I list is short: superficial mechanical injury, contact with weak cleaning materials, hot surfaces up to 50 degrees Celsius, eye damage from sunlight, and non-extreme weather.

Category II covers every risk that is not Category I or Category III. The Commission's classification guide places high visibility clothing and hand and arm protection here.

Category III covers risks that may cause death or irreversible harm, and Annex I names hazardous substances and mixtures, oxygen-deficient atmospheres, harmful biological agents, ionising radiation, extreme heat and cold, falls from height, electric shock, drowning and harmful noise. The same list covers cuts by hand-held chainsaws, high-pressure jets, and bullet or knife wounds.

Category II and III products need a Notified Body before CE marking

Article 19 sets out the conformity assessment procedures, and the category decides which one a product must follow.

Category I follows internal production control, Module A. The manufacturer keeps the technical documentation and issues the declaration. No Notified Body is involved.

Category II follows EU type-examination, Module B, then conformity to type based on internal production control, Module C. A Notified Body examines the technical documentation and a production-representative specimen before it issues an EU type-examination certificate (EUR-Lex).

Category III follows Module B, then either Module C2 or Module D. Module C2 adds supervised product checks at random intervals. Module D adds quality assurance of the production process, so a Notified Body stays involved after the type examination.

For Category III PPE, the CE marking is followed by the identification number of the Notified Body in the procedure, and that number is a quick signal to a customs officer or a buyer about which body stands behind the assessment (EUR-Lex).

The technical documentation and the declaration of conformity are the manufacturer's responsibility

A manufacturer draws up technical documentation before the conformity assessment, and Annex III sets out what it must contain and that it must stay available to market surveillance authorities.

The EU declaration of conformity is governed by Article 15, and it states that the applicable essential health and safety requirements have been met. It follows the model structure in Annex IX. By drawing it up, the manufacturer takes responsibility for compliance.

Under Articles 16 and 17, the CE marking is affixed visibly, legibly and indelibly before the product reaches the market. Where the PPE cannot carry it, it goes on the packaging and the accompanying documents.

Each product family has a harmonised standard that sets its test methods

Testing against the right standard turns a performance claim into evidence.

EN ISO 20471 specifies requirements for high visibility clothing that signals the wearer's presence in any light condition (ISO). EN ISO 13688 sets general performance requirements for protective clothing and is used with a standard for specific protective performance, never on its own (ISO).

For gloves, EN 388 covers mechanical risks (SATRA) and is read with EN ISO 21420:2020, the general requirements and test methods for protective gloves (ISO). EN 407 covers thermal risks and excludes firefighters and welders, which have their own standards (SATRA). Single-use medical gloves follow EN 455, which has four parts: freedom from holes, physical properties, biological evaluation and shelf life (European Standards).

EN 149 covers filtering half masks. It defines three classes, FFP1, FFP2 and FFP3, and it sets filtration, breathing resistance, total inward leakage and practical performance tests (SATRA).

Cut resistance alone keeps a glove in Category II, but chemical gloves and masks are Category III

A glove tested to EN 388 for cut protection sits in Category II under the hand and arm protection entry in the Commission's classification guide.

Category III applies where the glove addresses a listed Annex I risk, such as cuts by hand-held chainsaws, hazardous substances, harmful biological agents, live working or extreme temperatures. A chemical glove or a biological-protection glove therefore moves to Category III, and the stricter route follows.

The Commission's guide places respiratory protective equipment against solid aerosols, liquid aerosols or gases in Category III. That covers a filtering half mask tested to EN 149 as well as a reusable respirator. So a mask follows Module B plus Module C2 or Module D, and its CE marking carries the Notified Body's number.

Tti Labs tests and inspects PPE, and a Notified Body issues the certificate

Tti Labs operates ISO/IEC 17025 accredited testing (Tti Labs testing). Inspection runs through Tti Inspections, whose ISO/IEC 17020 accreditation (PNAC IB-006) covers product inspection of textiles, food and cosmeceuticals. PNAC accreditation LAB-022 records that Tti Labs complies with ISO/IEC 17025:2017 and holds an accredited scope (PNAC). For PPE exporters, Tti Labs provides:

• Testing to the harmonised standard for each product family, including EN 388, EN 407, EN ISO 20471 and EN 149. The published PPE scope covers protective gloves, protective clothing, protective footwear, motorcycle PPE and medical PPE, with the standards named above (Tti Labs PPE testing).

• Inspection of gloves, garments and footwear against the purchase order and buyer specification. Tti Labs' inspection service covers PPE garments, face masks and gloves (Tti Labs inspection).

• Support in assembling and reviewing the Annex III technical documentation.

• Coordination with Notified Bodies through the EU type-examination process.

• Laboratory reports that carry the measurements a Notified Body needs during conformity assessment.

Tti Labs is not a Notified Body. It does not issue EU type-examination certificates or CE certificates. That decision sits with a body notified under Regulation (EU) 2016/425, and only in the area for which it is notified. The Commission warns about certificates that look official but are not: a body acting outside its notification can issue a voluntary certificate, and under EU law that document is not a recognised means to prove compliance (European Commission).

Contact Tti Labs through the contact page to scope a PPE testing programme.

Book PPE testing and inspection with Tti Labs.

Related guides: Which Certificates Win the Order, and What They Cost, Lab Testing for Pakistan Exports: What Buyers Need to Verify.