EU REGULATION 2016/425 – PERSONAL PROTECTIVE EQUIPMENT (PPE)
Personal Protective Equipment (PPE) must be designed and manufactured to protect the user following the manufacturer’s instructions without causing harm to the user.
EU Regulation 2016/425, which came into force in April 2018, is the reference legislation for PPE; it classifies devices into the following categories
- Category I
Minor or minor risks (CE mark). PPE of simple design. PPE is subject to a self-certification procedure by the manufacturer, who is required to verify its conformity according to the technical standards and the essential health and safety requirements.
- Category II
This category includes PPE that is not covered by Category I and III (CE marking + risk pictogram). The PPE must be certified by a recognised European certifying body. They must pass a series of tests and inspections to ensure that they meet the standards laid down in the reference standards. The manufacturer is obliged to monitor Category IIa PPE to maintain the protection standards of the PPE over time.
- Category III
Risk of death or serious injury of a permanent nature (CE mark + risk pictogram + the number of the Certifying Body). PPE of complex design. PPE requires a certificate of conformity and regular production control at the manufacturer’s premises by Certifying Bodies; the obligation to monitor the PPE is the exclusive responsibility of the Certifying Body, which has issued the certificate attesting to the classification of the PPE in Category III.
EUROPEAN DIRECTIVE 93/42/EEC – MEDICAL DEVICES
According to the definition contained in d. According to the definition contained in legislative decree no. 46 of February 24, 1997 (implementation of European Directive 93/42/EEC), a medical device is any instrument, apparatus, implant, substance or other product, used alone or in combination, including the computer software used for correct operation and intended by the manufacturer to be used in man for diagnosis, prevention, control, therapy or mitigation of a disease; diagnosis, control, therapy, alleviation or compensation for an injury or handicap; study, replacement or modification of the anatomy or a physiological process; intervention in conception, the product of which does not exert its principal action, in or on the human body for which it is intended, by pharmacological or immunological means or by a metabolic process but whose function may be assisted by such means.
DM are classified into four classes: CLASS I, CLASS IIa, CLASS IIb and CLASS III according to their characteristics and the degree of risk associated with them (see ANNEX IX of Directive 93/42/EEC).
Depending on the class of the DM, it is necessary to choose the annexe of Directive 93/42/EEC that defines the conformity assessment procedure to be used.
- CLASS I – Annex VII
- CLASS IIa – Annex VII+IV
- CLASS IIb – Annex II (excl. point 4)
- CLASS III – Annex II (complete)
For CLASS I devices the intervention of a Notified Body is not required for conformity assessment, except for CLASS I STERILE devices and CLASS I MEASUREMENT devices.
For the other CLASSES, the intervention of a Notified Body carrying out specific activities according to the chosen ANNEX is mandatory.
EU REGULATION 2016/425 ON PPE
Sets out the requirements for the design and manufacture of PPE and designates the risk category, the minimum risk for PPE in Category I, the high biological risk for PPE in Category III.
Link to the complete regulation
UNI EN ISO 13688:2013 STANDARD
Specifies the general performance requirements for ergonomics, safety, size designation, compatibility and marking of protective clothing and the information to be provided by the manufacturer with the protective clothing.
Link to the full legislation
EU REGULATION 14126:2003
Establishes performance requirements for protective clothing against infectious agents.
ANTISTATIC PROPERTIES EN 1149-1:2006, EN 1149-5:2008
These standards regulate the characteristics of products with antistatic properties.
UNI EN 14605:2009 (type3/type4)
Protective clothing against liquid chemicals – Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items protecting parts of the body only.
EN 13982-1:2004 + A1:2010
The standard specifies minimum requirements for chemical protective clothing resistant to the penetration of airborne solid particles (Type 5).
The standard specifies the minimum requirements for chemical protective clothing for limited use and reusable with limited protection (Type 6).
UNI EN 13795-1/2019
The standard provides information on the characteristics of disposable and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infectious agents between patients and clinical staff during operations.
UNI EN ISO 22610:2006
The standard specifies a test method, with associated test apparatus, used to determine the resistance of materials to bacterial penetration, carried by a liquid when subjected to mechanical rubbing.
The standard deals with biocompatibility and biological safety standards for the evaluation of medical devices.
D.LGS. 24 FEBRUARY 1997, N.46 E S.M.I.
Surgical half masks are intended to prevent the wearer from contaminating the environment, as they limit the transmission of infectious agents and fall within the scope of medical devices under Legislative Decree no. 46 of 24 February 1997, as amended.
LAW DECREE 17 MARCH 2020 N.18
Commercially available surgical half masks (DM -Medical Device) are equivalent to PPE (Personal Protective Equipment).
UNI EN 14683:2019
Provides characteristics and test methods for surgical half masks, indicating the requirements of
- resistance to liquid splashes
- bacterial filtration efficiency
- cleanliness from microbes
UNI EN ISO 10993-1:2010
The technical reference standard has a general character for medical devices and provides evaluation and testing within a risk management process.
In vitro diagnostic medical devices.
Link to the full directive
It defines indispensable requirements such as
- Harmlessness (must be harmless for the user, hexavalent chromium content, PH level is checked, for natural rubber gloves the level of latex proteins is checked)
- Verification of construction (maximum protection and optimisation of performance)
- Compliance with standard sizes, except for special design gloves
- Instructions for use
- Compliance with the marking
The EN 388 standard, in its latest version of 2016, is the product standard that defines the characteristics, type and levels of protection against mechanical risks.
EN ISO 374:2016
The EN ISO 374:2016 standard defines the requirements for protective gloves against chemical and/or microbiological risks.
EN ISO 374-5:2016
This part of the standard sets out the requirements and methods for gloves intended to protect the user against micro-organisms.
UNI EN 455
This standard regulates the requirements necessary for a single-use glove intended for use in the medical field to perform its function of prevention and direct protection of the patient and the user from cross-contamination.
FOOD CONTACT (MATERIAL MOCA)
All Materials and Objects intended for Food Contact must be carefully controlled to prevent the risk of contamination and ensure compliance with health and safety requirements.
The reference standards are
- EC Regulation 1935/2004
- Health Ministerial Decree 21/03/1973 (natural or synthetic rubber gloves – see table 7)
- EU Regulation 10/2011 (plastic gloves – see table 8)
The device choice is subject to its suitability evaluation for contact with the specific foodstuff in the actual conditions of use, i.e. the possible transfer of substances between the foodstuff and the device is verified.
UNI EN 149:2009
Specifies the minimum requirements for anti-dust filtering half masks, used as respiratory tract protection devices (called FPP2 and FPP3), to guarantee the characteristics of efficiency, breathability, stability of the structure through technical tests and trials.