Putting PPE to the test for the cleanroom


The 20 year-old Personal Protective Equipment (PPE) Directive is being superseded by the PPE Regulation. Graham Clements, Product Development Manager, Personal Safety Certification at BSI explains the changes and requirements, and highlights why it is important for cleanroom professionals

The new EU PPE Directive makes several changes to PPE requirements for suppliers and users

The Personal Protective Equipment (PPE) Directive is now over 20 years old and to reflect current technologies and processes for developing and bringing PPE to the market, it is being superseded by the PPE Regulation. The PPE Directive was first adopted by the European Council on 21 December 1989. However, now the Directive is being superseded by a new European Regulation (EU) 2016/425 on personal protection equipment. The new Regulation was adopted on 12 February 2016 and then published in the Official Journal. It applies from 21 April 2018, with a one year transition period until 21 April 2019. All PPE manufactured after 21 April 2019 will need to comply with the new Regulation.

The PPE regulation is mandatory therefore in the PPE industry, it is a legal requirement to comply. Any health and safety professionals or facilities managers procuring PPE need to be aware of the changes, to ensure equipment meets the new regulation.

It is also worth being aware that while the previous directive focused on manufacturers placing products in the market, the new regulation involves the whole supply chain. This means that distributors or anyone in the supply chain should take appropriate measures to ensure that PPE meets the requirements. The new regulation has been developed to enhance consumer safety and ensure fair competition between companies.

The main changes

The main changes to the regulation include the following:

  • Moving hearing protection from Category 2 to Category 3 PPE
  • The need for a product risk assessment in the technical file
  • Enclosing a Declaration of Conformity with each PPE or at least a link to where it can be obtained
  • Clear placement of protection from substances and mixtures hazardous to health, and substances and mixtures hazardous to health in category 3
  • Responsibilities outlined for importers and distributors
  • Bespoke PPE are covered in the regulation
  • The need for manufacturers to place their name and address on the product bringing the regulation in line with similar European requirements such as the Medical Devices Directive by having a five-year certificate validity.
  • PPE Categories

    PPE can be described as

    a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety

    b) interchangeable components for equipment referred to in point (a) which are essential for its protective function

    c) connection systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use. There are three different categories for PPE:

    Category 1 — Simple PPE: PPE in this category is designed to protect users against minimal risks including contact with hot surfaces not exceeding 50°C, contact with water or cleaning materials of weak action and superficial mechanical injury.

    Category 2 — Intermediate PPE: This includes products such as safety spectacles and goggles, industrial helmets, bump caps, hi-viz clothing and other products not included in categories 1 and 3.

    Category 3 — Complex PPE: This category includes exclusively the risks that may cause serious consequences such as death or irreversible damage to health. Those risks include substances and mixtures that are hazardous to health, and harmful biological agents.

    PPE for medical use

    The Medical Devices Directive 93/42/EEC was amended on 5 September 2007 by Directive 2007/47/EC of the European parliament. This meant that: ‘Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC and this Directive [93/42/EEC], the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.’ The measures will apply from 21 March 2010.

    Implications for cleanroom products This means that any products worn or held by cleanroom staff for their protection from hazards as defined in both the current PPE Directive and the impending PPE Regulation, will need to be approved as PPE, even if they are also approved as medical devices. There are several products that are designed to keep cleanroom wearers safe where manufacturers and suppliers may not be fully aware of this requirement. Suppliers of PPE and end users will need to bear the following products in mind:


    • Clothing worn by clinical or cleanroom staff designed to protect the wearer from strong detergents, infectious agents, chemicals, harmful pharmaceuticals, ionising radiation, etc., included in Category 3 PPE
    • Clothing worn by clinical or cleanroom staff to protect from other hazards are also PPE, and the category will depend on the hazard and possible level of injury
    • A single item of clothing, or combination of items, may cover multiple hazards l Full and partial body clothing are included


    • Gloves worn by clinical or cleanroom staff designed to protect the wearer from strong detergents, infectious agents, chemicals, harmful pharmaceuticals, ionising radiation, etc., are Category 3 PPE
    • Gloves worn by clinical or cleanroom staff to protect from other hazards are also PPE, and the category will depend on the hazard and possible level of injury
    • A single type of glove may cover multiple hazards
    • Single use and reusable gloves are included Masks
    • Masks worn by clinical staff designed to protect the wearer from any respiratory hazard, are always Category 3 PPE
    • Surgical masks worn by clinical staff designed to protect the patient from the transmission of infectious agents from clinical staff to the patient only, are medical devices
    • Masks may do both, making them both PPE and medical devices

    Counterfeit goods?

    Today there are some fantastic protection products available on the market, however there are also numerous products that are not up to scratch. PPE is vital for safety, therefore it is important that the protection within a workplace meets, or exceeds the standards. The new regulation will help to prevent companies from being able to sell substandard products without being accountable. Under the new regulation, any company selling these products will have to keep records of any products that are manufactured and ensure products meet the required standards.

    How can organisations be confident a product will do what it claims?

    The BSI Kitemark gives a higher level of assurance that a product will do what it claims. It helps differentiate well-made PPE protection products from those of a lower standard — or indeed counterfeit goods. The BSI Kitemark is a voluntary, independent, third-party certification. To achieve it, a manufacturer must have a comprehensive quality management system based on ISO 9001, or a recognised factory production control system, combined with initial product type-testing and regular on-going audits. The certification process demonstrates the product has been manufactured using a verified quality system by the manufacturer, and the products and processes are assessed on a continuing basis.

    In addition, it provides verification that the product meets the standard, as it requires regular factory visits, typically twice a year, and an ongoing product audit. Certification to, and display of, an independent BSI Kitemark provides a much stronger statement of product quality than a CE mark, giving manufacturers the ability to differentiate their products — and providing customers with genuine assurance of product quality and fitness for purpose. BSI continues to work with manufacturers who achieve CE marking and also choose to go for certification with a BSI Kitemark to differentiate their products and use this as a demonstration of quality and trust.

    BSI recently extended its Hemel Hempstead Centre of Excellence for protective equipment testing, with the opening of a Gas Capacity Laboratory capable of testing the effectiveness of filters used in Respiratory Protective Equipment (RPE). This allows it to offer both RPE testing and gas capacity testing of filters against gases that may be encountered in some workplace situations.

    The introduction of the PPE Regulation might seem like a complex business, however by starting to prepare for these changes now, organisations can be better equipped to handle the impact. Importantly however it will give the peace of mind to consumers and organisations alike that the quality, safety and reliability of PPE products is guaranteed.