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European Directive 93/42/EEC on Medical Devices

If the appliance is at the same time a Medical Device within the meaning of Directive 93/42/EEC and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of the Directive.

'Medical Device' means any intrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for  human beings in the purpose of:

- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
- Investigation, replacement or modification of the anatomy or of a physiological process
- Control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.


Please Click Here for More Information: PDF Info Sheet on 93/42/EEC
 
ISO 9001:2008 Quality Management System

ISO 9001:2008 sets out the criteria for a Quality Management System and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organisation, large or small, regardless of its field of activity. In fact ISO 9001:2008 is implemented by over one million companies and organisations, in over 170 countries.

The standard is based on a number of Quality Management Principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001:2008 helps ensure that customers get consistent, good quality products and services.

Checking that the system works is a vital part of ISO 9001:2008. An organisation must perform internal audits to check how its Quality Management System is working.

Please Click Here for More Information: Info Sheet on ISO 9001:2008


 
ASTM D3577/91

This specification covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type (Type 1) and of the synthetic rubber latex type (Type 2). The gloves shall be manufactured from any rubber polymer compound, with the inside and outside surfaces of the gloves free of talc. and with dimensions and physical properties that shall conform to the requirements specified. Tests for sterility, freedom from holes, physical dimensions, tensile strength, ultimate elongation, stress and elongation, powder-free residue, powder amount, protein content and antigenic protein content shall be performed to assess the conformance of the rubber gloves with the requirements specified.

Please Click Here for More Information: Info Sheet ASTM D3577/91

 
ASTM D6319-99

This is a specification that evaluates the performance and safety of Nitrile Rubber Gloves, for use in conducting medical examinations, diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile or nonsterile or bulk nonsterile.

Please Click Here for More Information: Info Sheet ASTM D6319-99


 
EN 374:2003 Gloves Giving Protection from Chemical and Micro-Organisms

Scope:
This standard specifies the capability of gloves to protect the user against chemical and/or micro-organisms.

Definitions:

Penetration
Penetration is the movement of a chemical and/or micro-organism through porous matierals, seams, pinholes or other imperfections in a protective glove material at a non-molecular level.

Permeation
The rubber and plastic films in gloves do not always act as barriers to liquids. Sometimes they can act as sponges, soaking up the liquids and holding them against the skin. It is therefore necessary to measure breakthrough times, or the time taken for the hazardous liquid to come in contact with the skin.


Requirements:

Minimum Liquid Proof Section
The minimum liquid proof section of the glove shall be at least equal to the minimum length of the gloves specified in EN 420.

Penetration
A glove shall not leak when tested to an air and/or water leak test, and shall be tested and inspected in compliance with the Acceptable Quality Level.

 
Performance Level Acceptable Quality Level Unit Inspection Levels
Level 3 < 0.65 G1
Level 2 < 1.5 G1
Level 1 < 4.0 S4

The 'Chemical Resistant' glove pictogram (above) must be accompanied by a 3-digit code. This code refers to the code letters of 3 chemicals (from a list of 12 standard defined chemicals), for which a breakthrough time of at least 30 minutes has been obtained.

 
Code Letter Chemical Cas Number Class
A Methanol 67-56-1 Primary Alcohol
B Acetone 67-64-1 Ketone
C Acetonitrile 75-05-8 Nitrile Compound
D Dichloromethane 75-09-2 Chlorinated Paraffin
E Carbone Disulphide 75-15-0 Sulphur containing Organic Compound
F Toluene 108-88-3 Aromatic Hydrocarbon
G Diethylamine 109-89-7 Amine
H Tetrahydrofurane 109-99-9 Heterocyclic and Ether Compound
I Ethyl Acetate 141-78-6 Ester
J n-Heptane 142-82-5 Saturated Hydrocarbon
K Sodium Hydroxide 40% 1310-73-2 Inorganic Base
L Sulphuric Acid 7664-93-9 Inorganic Mineral Acid

Permeation
Each chemical tested is classified in terms of breakthrough time (performance level 0 to 6).

 
Measured Breakthrough Time Protection Index Measured Breakthrough Time Protection Index
> 10 minutes Class 1 > 120 minutes Class 4
> 30 minutes Class 2 > 240 minutes Class 5
> 60 minutes Class 3 > 480 minutes Class 6


The 'Low Chemical Resistant' or 'Waterproof' glove pictogram (above) is to be used for those gloves that do not achieve a breakthrough time of at least 30 minutes against at least three chemicals from the defined list, by which comply with the Penetration Test.


The 'Micro-organism' pictogram (above) is to be used when the glove conforms to at least a performance level 2 for the Penetration Test.

WARNING: The Chemical Data Information does not necessarily reflect the actual duration in the workplace.


 
EC 1935/2004 Food Contact Materials

General Principles of the Framework Regulation
The Regulation - in force since 3rd December 2004 - requires that food contact materials must follow:
- Are safe
- Must not transfer their components into food in quantities that could endanger human health, change food composition in an unacceptable way or deteroriate its taste and odour
- Are manufactured according to good manufacturing practice
- An article intended for food contact must be labelled or bear the glass-and-fork symbol. This labelling is not obligatory if food contact is obvious by the article's nature e.g. knife, fork, wine glass.
- Labelling, advertising and presentation of food contact materials must not mislead consumers.
- Information on the appropriate use of food contact materials or articles must be provided, if necessary
- Are traceable throughout the production chain.

 
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Groups of Materials and Articles
The Regulation establishes 17 groups of materials and articles which may be covered by specific measures. The specific measures may cover also combinations of different materials or recycled materials:
- Active and intellgient materials and articles
- Adhesives
- Ceramics
- Cork

- Rubbers
- Glass
- Ion-exchange resins
- Metal and alloys
- Paper and board
- Plastics
- Printing inks
- Regenerated cellulose
- Silicones
- Textiles
- Varnishes and coatings
- Waxes
- Wood

There are specific measures for ceramics, regenerated cellulose, plastics, recycled plastics and active and intelligent materials and articles. The Regulation includes definition on active and intelligent packaging. If the materials release substances in the food that change the food composition or properties, then these substances must comply with food legislation e.g. food additives.

These materials and articles cannot be used to mask spoilage of food and mislead the consumer.

European Directive 89/686/EEC on Personal Protective Equipment (PPE)

1) This Directive applies to personal protective equipment, here-inafter referred to as 'PPE'. It lays down the conditions governing its placing on the market and free movement within the Community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users. 

2) For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.

PPE shall also cover:

(a) A unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks;

(b) A protective device or appliance combined, separably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity;

(c) Interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment

3) Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the use for the entire period of risk exposure.

4) This Directive does not apply to:

- PPE covered by another Directive designed to achieve the same objectives as this Directive, with regard to placing on the market, free movement of goods and safety.
- the PPE classes specified in the list of excluded product in Annex I, independently of the reason for exclusion mentioned in the first indent.


Please Click Here for More Information: European Directive 89/686/EEC

 
EN388 Protective Gloves Against Mechanical Risks

This Standard uses different types of equipment to assess the properties of gloves, which is symbolised by the pictogram above.

A Martindale Wear and Abrasion Tester measures the abrasion resistance of the glove. Samples of the glove's material are rubbed against glass paper, until a hole is worn. The number of abrasion cycles required to make the hole is recorded.

A Sodemat Cut Tester measures cutting resistance. Samples are cut from the gloves and placed into a frame where a circular, counter-rotating blade slices through the glove material. The number of cycles of the blade is recorded and converted into a cutting index.

A Tensometer measures Puncture and Tear Resistance. Puncture Resistance is measured as the force required to break through the gloves, using a standard puncture needle - this is more like a large nail and not a hyopdermic needle. Tear Resistance is measured as the force required to tear apart the glove material, which are in the form of a pair of trousers.


 
EN455 Medical Gloves for Single Use

Part 1 Requirements and Testing for Freedom From Holes
Gloves must pass this test in order to prove that they are an effective barrier against micro-organisms. A statistical sample taken from a batch of gloves is subject to checks for pinholes and leaks by filling with water. Gloves must achieve an acceptable quality level (AQL) of 1.5 or better in order to be used as examination, procedure or surgical gloves. 

AQL 1.5 is equivalent to a maximum risk of 1.5% that any given glove contains a pinhole capable of allowing water, and therefore micro-organisms, through the film.

Part 2 Requirements and Testing for Physical Properties
This standard includes tests for glove dimensions, and physical strength. Gloves are treated differently depending on the use they are intended for and the material they are manufactured from.

 
Surgical Gloves Examination/Procedure Gloves made of Rubbers Examination/Procedure Gloves made of Thermoplastic (e.g Vinyl)
Force at Break Throughout Entire Shelf Life 9.0 6.0 3.6

Part 3 Requirements and Testing for Biological Evaluation
This standard includes tests for potentially hazardous materials that may affect the wearer or be transferred to a patient. These materials include:

- Endotoxins: Toxic materials left behind by certain bacteria that can cause fever in humans
- Latex Proteins: Because natural rubber latex is a natural product it contains proteins and enzymes that can cause a severe allergic reaction in genetically predisposed people.
Chemical Residues: Most commonly, accelerators used in the manufacture of the product itself. These can cause allergic dermatitis in some genetically predisposed individuals. 
- Powder: A powder free medical glove should have a powder level of <2mg per glove

The materials above are tested individually as well as collectively, through the use of limited animal testing according to a separate standard, ISO10993

Part 4 Determination of Shelf Life
This standard requires a complicated network of tests to determine how long a glove will be fit for use when stored in warehouses or in end-user store rooms. All calculations on this testing must be checked by comparison to samples aged in real-time as soon as those samples become available. The maximum shelf-life that can ever be claimed for medical gloves is five years from the date of manufacture.


 
BS EN  1276:2009 Chemical Disinfectants and Antiseptics. Quantitative Suspension Test for the Evaluation of Bactericidal Activity of Chemical Disinfectants and Antiseptics Used in Food, Industrial, Doemstic and Institutional Areas. Test Method and Requirements (Phase 2, Step 1)

BS EN 1276 is a European Standard which specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - the case of ready-to-use products - with water.

Products can only be tested at a concentration of 80% or less, as some dilution is always produced by adding the test organisms and interfering substance.

BS EN 1276 applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas.

In order to pass this standard, products must prove a bacteria kill rate of 99.999% in 5 minutes.


 
Cosmetic Regulations



Please Click Here for More Information on the Cosmetics Regulation: Cosmetic Regulation Info. 

 
Cosmetic Grade Ingredients
Cosmetic Grade Ingredients are ingredients that have received the required testing and approval for use in cosmetics such as colorants, dyes or fragrance oils which will come into direct contact with your skin.

 
BSEN 13727
Method of Test for Petroleum and its products. BS 2000-527 Petroleum products and lubricants. Determination of low-temperature cone-penetration of lubricating greases.

 
Triclosan
Triclosan is a chemical ingredient of cosmetics, soaps, detergents, shampoos and toothpaste, used to prevent bacterial contamination. It is a controversial ingredient that has undergone research from the University of California (funded by US Public Health Services Grants). The study involved exposing mice to high doses of Triclosan on a daily basis for six months, which was found to cause the mice to suffer liver damage and became more susceptible to liver tumours induced by other cancer-causing chemicals. 

Despite this factor the MHRA (The Medicines and Healthcare Products Regulatory Agency), equivalent of the FDA in England, does not appear to have made an equivalent investigation. Due to the fact that Humans do not experience such a high level of Triclosan on a daily basis and due to the size and biology of mice, in comparison to humans, Triclosan is still able to be used in different products and remains non-hazardous.

Please Click Here for More Information on Triclosan: Triclosan Info.

 
BS EN 1500 Chemical Disinfectants and Antiseptics - Hygiene Handrub - Test Method

Artificially-contaminated hands are assessed before and after, using the hygienic handrub. Human subjects are used. Antimicrobial activity is monitored, recorded and assessed.

 
EN 13704:2002 Chemical Disinfectants. Quantitative Suspenstion Test for the Evaluation of Sporicidal Activity of Chemical Disinfectants used in Food, Industrial, Domestic and Institutional Areas. Test Method and Requirements (phase 2, step 1) (British Standard)

The European Standards specifies a test method (phase 2/step 1) (see annex H) and the minimum requirements for sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard water and that are used in food, industrial, domestic and institutional areas, excluding areas and situtations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas.

Using this European Standard, it is not possible to determine the sporicidal activity or undiluted product as some dilution is always produced by adding the inoculum and interfering substance. Products can only be tested at a concentration of 80% or less. NOTE: The method described is intended to determine the activity of commercial formulations or active substances on spores in the conditions in which they are used.


 
Halal Approved

Halal is an Arabic word with means 'permitted', 'allowed', 'lawful' or 'legal. The opposite of Halal is Haram which means 'prohibited', 'not allowed', 'unlawful' or 'illegal'. Halal Approved means a product is following the laws of the Muslim faith and does not contain Animal Substances, Intoxicants or Alcohol. In terms of Food and Cosmetics, any product consumed or used by an individual of the Muslim faith must be free from ALL items listed below, including any by-products derived from the items below:

- Pig or Dog
- Blood

- Part or by-product of the human body e.g. human hair in L-Cysteine
- Carnivorous Animals
- Birds with talons or birds that feed by snatching and tearing e.g. eagles and other similar birds
- Reptiles and Insects
- Animals which are 'generally considered as repulsive' such as lice, maggots, mice, rats, spiders and other similar animals
- Any marine animals, except fish
- Animals that live on land and in water (amphibians) like frogs, crocodiles and other similar animals
- Animals which have died, by any means other than slaughtering, according to the Islamic Law
- Animals permitted under the Islamic Law (i.e. cow, sheep, lamb, goat, poultry etc.) which are not slaughtered according to the Islamic Law
- Wine, Ethyl Alcohol or Spirits
- Intoxicating and hazardous plants
- Food/Cosmetic Products contaminated with any of the above