CERTIFICATION OF PPE &

HYGIENE PRODUCTS
Speaker: Shridhar Rajpurohit

BE THE BENCHMARK
CERTIFICATION & BUSINESS ENHANCEMENT SOLUTIONS
CONTENT

 What is PPE?
 What is not PPE?
 What are the types of PPE?
 CE Marking Certification of PPE
 How does PPE Certification ensures safety?
 Principles of CE Certification
 Understanding the modules for PPE certification
 Who are the notified bodies?
 Hand sanitizers (Hygiene Products)
 Formulation, types, usage & impact of sanitizers
 Consensus & Recommendations
 Testing & Certification for Sanitizers

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WHAT IS PPE?

 “Any device or appliance

designed to be worn or held
by an individual for protection
against one or more safety
hazards”

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WHAT IS NOT PPE?

 Specifically designed for use by the armed forces or for the maintenance of law and
order
 Designed to be used for self-defence, with the exception of PPE intended for
sporting activities
 Intended for private use to protect against
 Atmospheric conditions that are not of an extreme nature
 Damp and water during dishwashing;
 For exclusive use on seagoing vessels or aircraft that are subject to the relevant
international treaties applicable in member states
 For head, face or eye protection of users covered by Regulation No 22 of the
United Nations Economic Commission for Europe on uniform provisions concerning
the approval of protective helmets and their visors for drivers and passengers of
motor cycles and mopeds.

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 WHAT ARE THE TYPES OF PPE?
PPE CATEGORY I
Superficial mechanical injury

Contact with cleaning materials of weak action or prolonged contact with

water;

Contact with hot surfaces not exceeding 50°C

Damage to the eyes due to exposure to sunlight (other than during

observation of the sun)

Atmospheric conditions that are not of an extreme nature.

PPE CATEGORY I
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 WHAT ARE THE TYPES OF PPE?
PPE CATEGORY II
Safety and sports helmets

High visibility clothing

Protection against serious mechanical injury, e.g. metal working gloves, safety
footwear.

Buoyancy aids

Immersion suits/wet suits

Motorcycle clothing & high risk sports protective equipment

PPE CATEGORY II
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WHAT ARE THE TYPES OF PPE?
PPE CATEGORY III
 Substances and mixtures  Atmospheres with oxygen
which are hazardous to deficiency
health

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WHAT ARE THE TYPES OF PPE?
PPE CATEGORY III
 Harmful biological agents  Ionising radiation

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WHAT ARE THE TYPES OF PPE?
PPE CATEGORY III
 High-temperature environments
the effects of which are
comparable to those of an air
temperature of at least 100°C
 Low-temperature environments
the effects of which are
comparable to those of an air
temperature of – 50 °C or less
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WHAT ARE THE TYPES OF PPE?
PPE CATEGORY III
 High-temperature Falling  Electric shock and live
from a height working

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WHAT ARE THE TYPES OF PPE?
PPE CATEGORY III
 High-pressure jets  Cuts by hand-held
chainsaws

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WHAT ARE THE TYPES OF PPE?
PPE CATEGORY III
 Bullet wounds or knife  Harmful Noise
stabs

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CE CERTIFICATION OF PPE

CE stands for “Communaute Europeene” meaning “ European Community.”

CE certification mark on products of health , safety ,and environment

Origin from Europe – in Europe there is an excellence regulating authority within EEA ( European Economic Area
) which validates the quality of their listed products .

Originally it was known as EC mark but it was improved as CE Mark in Year 1993 .

Even products exported from other countries to EEA can have CE marking as made by compulsory by EEA for
meeting and conforming EEA standards .

CE marking verifies that the product has been assessed to meet EU safety , health and environmental
necessities , it is valid then to market your product in EEA

CE – marking as “passport for free exchange of Goods ”

It is a conformity label to guarantee the correspondence to the harmonized, requirements , the products can be
marked with sign if all obligatory product requirements are fulfilled .

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HOW DOES PPE CERTIFICATION ENSURES SAFETY?

Clients are guaranteed about the product conformation as per

the rules set with respect to the specific directive

The manufacturers gain freedom of making their products totally

available in the European Economic market .

By strictly possessing the CE mark on the product will reduce the

negative claims as well as problem premiums

Manufacturers can say that their products are safe and healthy to be
used.

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PRINCIPLES OF CE CERTIFICATION

Essential Requirements

Technical Documentation

Product Categorization

Conformity Assessment

Notified Bodies

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PRINCIPLES – CE MARKING GUIDANCE

Guidance is contained in the “ blue book”

The 'Blue Guide' on the implementation of EU

product rules 2016’

Available on the web

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ESSENTIAL REQUIREMENTS

Lay down the necessary[design] elements for protecting the

public interest

Mandatory: Only products complying with essential requirements

may be placed on the European market and put into service

Must be applied as a function of the hazards inherent in the

product

In PPE Regulation (EU) 2016/425 these are known as the

Essential Health and Safety Requirements

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TECHNICAL DOCUMENTATION
The manufacturer must produce a
technical file [technical documentation]
Technical file must provide information on
how the product Is designed,
manufactured, tested and information for
its use
Show how the product meets the Essential
Requirements
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CONFORMITY ASSESSMENT

Manufacturer must subject the product to the conformity

assessment procedure before being able to legally affix the
CE mark and place the product on the European market

It can apply to the design phase and/or the production phase

of the product

It will be based on standard modules, some requiring

manufacturer’s actions and some third party intervention

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FLOW CHART FOR CONFORMITY ASSESSMENT

Technical file Type of

Manufacturer
(Annex III) Product

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 CONFORMITY ASSESSMENT- CATEGORY I

Manufacturer’s EU
Category I Declaration of CE certification
Conformity

• No requirement for Notified Body involvement

• Manufacturer requires
 Testing
 Technical file
• Self declaration by means of an EU Declaration of
Conformity

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 CONFORMITY ASSESSMENT- CATEGORY II

Manufacturer’s EU
Module B
Category II Declaration of CE
Certification
Conformity

• Manufacturer requires
 Testing
 Technical file
• Module B certification from Notified Body

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 CONFORMITY ASSESSMENT- CATEGORY III

Module C2 or Manufacturer’s
Module B
Category II D EU Declaration CE 0120 CE 0598
Certification of Conformity
Certification

• Manufacturer requires
 Testing
 Technical file
• Module B certification from Notified Body
• Module C2 or D certification from Notified Body ,Annual audits
(ongoing income)
• Scope for other certification 9001, 14001 etc

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 MODULES FOR PPE

 First party – manufacturer

 Module A = Internal control of
production
 Module C = Conformity to type
 Third party – Notified Body
 Module B = EU type examination
 Module C2 = Conformity to type
 Module D = Production quality
assurance

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SIMPLIFIED FLOW CHART OF MODULES

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MODULES (CONTINUED)

The modules are described in detail in EU Council Decision of

22 July 1993 (93/465/EEC)

concerning the modules for the various phases of the

conformity assessment procedures and the rules for the affixing
and use of the CE conformity marking, which are intended to be
used in the technical harmonization directives

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WHO ARE THE NOTIFIED BODIES?

 Carry out the conformity assessment tasks when third party

involvement is required
 Must be based in a EU member state and be approved by that state
 Can work in all countries
 Approval must be based on the appropriate ISO 17021 or ISO
17065 standards – SGS is ISO 17065
 Each have identifying number e.g. SGS = 0120

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 EU TYPE EXAMINATION CONSISTS OF ( MODULE B)

Issuance of EU type Examination Certificate

(for products type Ii & III)
 Evaluation of the technical file by
the applicant
Declaration of conformity by Manufacturer
 Testing of the PPE sample as
per harmonized standard
 The Notified Bodies (NB) have
to check the accordance of the CE marking
products with the essential
requirements and standards (
Annex V of PPE Regulation
2016)
CE CE 0598

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MODULE D – CERTIFICATION OF CATEGORY III PPE
–DIRECTIVE 2016/425 .

 CATEGORY III Products protecting against “Risks that may cause very
serious consequences such as death or irreversible damage to health”
 EU TYPE EXAMINATION + SURVEILLANCE Manufacturers require an EU
type-examination certificate and ongoing assessment of compliance. For the
latter, clients can choose to have their Notified Body:
 Audit the manufacturing site annually to ensure that quality management
systems are in place to manufacture a compliant product on an ongoing basis,
or Select samples annually for compliance testing
 SINCE 21 APRIL 2018, PPE PRODUCTS FALL WITHIN THE SCOPE OF
EU REGULATION – REGULATION (EU) 2016/425 – AND ON THE SAME
DATE DIRECTIVE 89/686/EEC WAS REPEALED.

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HAND SANITIZERS TESTING &
CERTIFICATION
HAND SANITZIER FORMULATION

WHO recommends one that is miscible in water and alcohol, is non-toxic, or a

hypoallergenic. A popular humectant that meets all these requirements is 98%
Glycerol. You can also use other humectants such as Aloe Vera Gel.

CDC recommends washing hands with soap and water whenever possible because
handwashing reduces the amounts of all types of germs and chemicals on hands.
But if soap and water are not available, using a hand sanitizer with at least 60%
alcohol can help you avoid getting sick and spreading germs to others.

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SANITIZER –TYPES AND USAGE

Hand sanitizer is a liquid or gel generally used to decrease infectious agents on the hands. ...

Alcohol-based versions typically contain some combination of isopropyl alcohol, ethanol (ethyl
alcohol), or n-propanol.

Hand sanitizer is a product which may be in liquid, form or gel, or pressurized containers in a
spray form or sometimes in form of foam generating product Hand Sanitizers are generally
used to decrease infectious agents on the surface of hands.

In most healthcare settings alcohol-based hand sanitizers are preferable to hand washing with
soap and water.

Reasons include it being better tolerated and more effective.

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IMPACT OF HAND HYGIENE PROMOTIONS ON HCAI

Failures to perform appropriate hand hygiene is considered to

be the leading cause of HCAI and spread of multi resistant
organisms and resulted in significant contributor outbreaks .

Outbreak investigations have suggested an association between

infection linked with poor hand hygiene .

The hand hygiene improves health and reduces upper

respiratory pulmonary infections , diarrhea and impetigo.

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CONSENSUS AND RECOMMENDATIONS

The recommendations were formulated based on evidences - by experts –like HICPAC (healthcare
infection control practices advisory committee ) of the centers for Disease Control and Prevention (CDC)-

-Hand hygiene technique with alcohol based formulation – for 20 to 30 seconds

-hand technique with soap and water -40 to 60 seconds

-Selection and handling of hand hygiene agents

-Skin care , Use of Gloves

-Educational and motivational programs for HCW ( Healthcare workers)

-Governmental and institutional responsibilities

-The selection of hand sanitizers products be efficacious and as safe as for the skin is utmost important

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HAND SANITIZER TESTING

The new standard, E2755, Test Method for Determining the Bacteria-Eliminating
Effectiveness of Hand Sanitizer Formulations Using Hands of Adults, was developed by a
task group within Subcommittee E35.15 on Antimicrobial Agents.

The BIS Standard Reference –IS 1061:2017 –suggest test parameters like –composition
and description , stability after dilution , Germicidal value , Mercury compound , stability on
storage ,detection of phenolic compounds

In Europe, the most commonly used methods to test hand antiseptics are those of the
European Committee for Standardization (CEN). In the USA and Canada, such formulations
are regulated by the Food and Drug Administration (FDA) and Health Canada, respectively,
which refer to the standards of ASTM International (formerly, the American Society for
Testing and Materials).

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HAND SANITIZER TESTING

Some of Significant Test methods for European standard – CEN Standards –EN 1499 and EN 1500 –
for culture of E Coli , and formulation of hand rub/hand sanitizers with respect to alcohol content .

ASTM 1838- for Viruses

ASTM E 2276 – method for bacteria

ASTM – E -2613-method for Fungi

ASTM –E-2011 - method for viruses

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CERTIFICATIONS FOR SANITIZERS

BIS test

On Global Platform – ISO 9001-2015

Added Advantage for manufacturers if integrated with IM S- QMS (9001-2015) , EMS( 14001-2015 for
Environment Management ) ISO 45001 -2018 – OHSAS) for quality , environment and
occupational hazard controls

SGS is globally having wide based clientele for above type certifications for almost industrial sectors

SGS also execute gap assessments for above type certifications and recommendation for required
documentation and implementation

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 THANK YOU

Contact Us: Email: Cbe.Marketing@sgs.com Toll Free No: 1800 10 33449

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