FORM 1:
PROPOSAL FOR A NEW FIELD OF TECHNICAL ACTIVITY
Circulation date2019-05-21

Reference number: Enter Number(to be given by ISO Central Secretariat)

Closing date for voting
2019-08-13
Proposer
SAC

ISO/TS/P 280

A proposal for a new field of technical activity shall be submitted to the ISO Central Secretariat,
which will assign it a reference number and process the proposal in accordance with the ISO/IEC
Directives Part 1, Clause 1.5. The proposer may be a member body of ISO, a technical committee,
subcommittee or project committee, the Technical Management Board or a General Assemblycommittee, the Secretary-General, a body responsible for managing a certification system
operating under the auspices of ISO, or another international organization with national bodymembership. Guidelines for proposing and justifying a new field of technical activity are given in
the ISO/IEC Directives Part 1, Annex C.

Proposal (to be completed by the proposer)
Title of the proposed new committee (The title shall indicate clearly yet concisely the new
field of technical activity which the proposal is intended to cover).
Laboratory Design

V01/2019

Form 1: Proposal for a new field of technical activity
Page 2

Scope statement of the proposed new committee (The scope shall precisely define thelimits of the field of activity. Scopes shall not repeat general aims and principles
governing the work of the organization but shall indicate the specific area concerned).
Standardization in the field of laboratory design including site selection and design planning, thefunctional division of experimental areas, the determination of scientific and technological processes,
layouts and design of furniture, and the scientific design of the facility taking into accountenvironmental conditions and impact.
Excluded:•

IEC/TC 64 (Electrical installations and protection against electric shock);•

IEC/TC 81 (Lightning protection);•

IEC/TC 66 (Safety of measuring, control and laboratory equipment);•

IEC/TC 85 (Measuring equipment for electrical and electromagnetic quantities).

Once the new TC is established, liaisons with other relevant ISO technical committees will beestablished, including ISO/TC 48（laboratory equipment）, ISO/TC 212 （Clinical laboratory testingand in vitro diagnostic test systems）and CASCO as well as relevant IEC technical committees(IEC/TC 45(Nuclear instrumentation), IEC/TC 62 (Electrical equipment in medical practice), IEC/TC
65 (Industrial-process measurement, control and automation), IEC/TC 76 (Optical radiation safety andlaser equipment) and IEC/TC 104 (Environmental conditions, classification and methods of test).
Note: the TC will support the contribution of the laboratory design industry to UN Sustainable
Development Goals and enable countries to address a wide range of global issues including
eradication of hunger and poverty, health, climate change and economic development.

The proposer has checked whether the proposed scope of the new committee overlaps
with the scope of any existing ISO committee
If an overlap or the potential for overlap is identified, the affected committee has been
informed and consultation has taken place between proposer and committee on
i. modification/restriction of the scope of the proposal to eliminate the overlap,
ii. potential modification/restriction of the scope of the existing committee toeliminate the overlap.
If agreement with the existing committee has not been reached, arguments arepresented in this proposal (under question 7) as to why it should be approved.

V01/2019

Form 1: Proposal for a new field of technical activity
Page 3

Proposed initial programme of work. (The proposed programme of work shall correspondto and clearly reflect the aims of the standardization activities and shall, therefore, show
the relationship between the subject proposed. Each item on the programme of work shallbe defined by both the subject aspect(s) to be standardized (for products, for example,
the items would be the types of products, characteristics, other requirements, data to besupplied, test methods, etc.). Supplementary justification may be combined withparticular items in the programme of work. The proposed programme of work shall alsosuggest priorities and target dates.)
The new TC will stipulate technical design requirements for a diverse range of laboratories with different
functions and responsibilities. It will include, but not limited to:
1. site selection and design planning;
2. layouts and design of furniture (e.g workbenches, fume hoods, safety showers, biological safetycabinets, etc);
3. electrical, water and gas supply systems, drainage, fire prevention, HVAC, auto-control anddecoration;
4. laboratories featuring bio-safety, constant temperature and humidity, and other special
laboratories;
5. laboratory safety, staff health, environmental protection, and energy saving;
6. Smart laboratory (use of new technologies such as big data, cloud computing, block chain, etc.
to empower laboratories, e.g. increase the depth and width of services provided to clients,
improve the servicing level during the consulting, design and maintenance phases.).
Initial Work Programme over 3 to 5 years will develop and prepare common design requirements fordifferent types of laboratories and submit international standards (IS): “General Specification ofTechnical Requirements for Laboratory Design” and “Technical Requirements for Smart Laboratory
Design”.
The programme will:a. build the framework for drafting “General Specification of Technical Requirements forLaboratory Design”;
b. classify laboratory types and define terminology;c.

clarify the principles of laboratory design requirements for various disciplines andacceptance requirements of laboratory functions;d. clarify the technical design requirements for laboratories utilizing digital technologies forbuilding management and environmental control;e. prepare IS “General Specification of Technical Requirements for Laboratory Design”;
f.

prepare IS “Technical Requirements for Smart Laboratory Design”.

Based on categorization of laboratory types and framework of the “Technical Requirements ofLaboratory Design”, future Work Programme over a period of 3 to 5 years will develop the technicalrequirements for design of various types of laboratories, e.g. food and agricultural product, medical,
pharmaceutical, petrochemical, university etc.

V01/2019

Form 1: Proposal for a new field of technical activity
Page 4

Indication(s) of the preferred type or types of deliverable(s) to be produced under the
proposal (This may be combined with the "Proposed initial programme of work" if moreconvenient).
Combined with “Proposed initial programme of work”.

A listing of relevant existing documents at the international, regional and national levels.
(Any known relevant document (such as standards and regulations) shall be listed,regardless of their source and should be accompanied by an indication of theirsignificance.)
1. There are no recognised international standards on any major aspect of Laboratory Design. Many
countries have formulated national building, safety and laboratory design regulations andguidelines but no global systematic standards on laboratory design that can be widely applied
across the world have been developed.
2. China has released some national standards related to laboratory design and construction.
3. Standards Australia/New Zealand has issued a Laboratory design and construction Standard(AS/NZS 2982:2010).
4. Standards and guidelines of relevance to the work of the proposed TC from China and othercountries are listed in Annex 1.
Country/
Organization

Standard headlines

Laboratory category

Australia/New
Zealand
China
China
China
China

AS/NZS 2982:2010 Laboratory design and construction

Generallaboratory ／specialized laboratory
Biology laboratory
Biology laboratory
Testing Laboratory
Scientificresearchlaboratory

China

GB/T 32146.1-2015 Technical requirements of design and construction forinspection and testing laboratory- Part 1:general specification

Testing laboratory

China

GB/T 32146.2-2015 Technical requirements of design and construction forinspection and testing laboratory- Part 2:Electrical laboratory

Testing laboratory

China

GB/T 32146.3-2015 Technical requirements of design and construction forinspection and testing laboratory- Part 3:Food laboratory

Testing laboratory

GB50346 Biosafety Laboratory Building Specification
GB19489 Laboratory - General Requirements for Biosafety
GB/T27476.1 Safety of Testing Laboratory
JGJ 91-93 Design code for scientific experiment buildings.

A statement from the proposer as to how the proposed work may relate to or impact on
existing work, especially existing ISO and IEC deliverables. (The proposer should explain
how the work differs from apparently similar work, or explain how duplication and conflict
will be minimized. If seemingly similar or related work is already in the scope of othercommittees of the organization or in other organizations, the proposed scope shalldistinguish between the proposed work and the other work. The proposer shall indicate
whether his or her proposal could be dealt with by widening the scope of an existingcommittee or by establishing a new committee.)
The mission of the proposed TC is to set up a series of standards on technical requirements for thedesign and construction of different types of laboratories, and develop standards of smart laboratories
based on digital technologies. At present, there is no ISO TC or SC covering laboratory design.
ISO17025 and ISO TC48 mention laboratories but do not cover laboratory design. ISO17025 merelyrefers to laboratory environment and equipment and is limited to a broad quality management
requirement. ISO TC48 is limited to standards for laboratory equipment and glassware and has noconflict with the standards to be drafted by the proposed new TC.

V01/2019

Form 1: Proposal for a new field of technical activity
Page 5A listing of relevant countries where the subject of the proposal is important to theirnational commercial interests.
Laboratories are a key component supporting both private and public sectors in a sustainable economy,
including agriculture and healthcare. The outcomes and outputs of the proposed TC should be ofinterest to a great number of countries, including those in developed and emerging economies. It would
enable countries to address a wide range of global issues and reach the UN Sustainable Development
Goals (SDGs)including eradication of hunger and poverty, health, climate change and economic
development.

A listing of relevant external international organizations or internal parties (other ISO
and/or IEC committees) to be engaged as liaisons in the development of thedeliverable(s). (In order to avoid conflict with, or duplication of efforts of, other bodies, it
is important to indicate all points of possible conflict or overlap. The result of any
communication with other interested bodies shall also be included.)
1.Internal parties: these are all committees named above.
a. ISO committees: ISO/TC 48, ISO/TC 212 and CASCO;b.

IEC committees: IEC/TC 45, IEC/TC 62, IEC/TC 64, IEC/TC 65, IEC/TC66, IEC/TC 81,
IEC/TC 76, IEC/TC85 and IEC/TC 104.

2.External organizations:a.
Union Internationale des Laboratoires Indépendants (UILI);b.

V01/2019

European Federation of National Associations of Measurement, Testing and Analytical
Laboratories (EUROLAB).

Form 1: Proposal for a new field of technical activity
Page 6

A simple and concise statement identifying and describing relevant affected stakeholder
categories (including small and medium sized enterprises) and how they will each benefit
from or be impacted by the proposed deliverable(s).
The setting up of laboratory design TC and establishment of laboratory design standards will benefit
organizations and groups as follows:
1.

Laboratory owners (including governments, scientific agencies and enterprises, etc.):
Laboratory owners will understand the principles and methods of laboratory design for better
management of laboratory design, construction, acceptance and operation. The investment budget
will have a reference basis; construction cost will be better controlled; investment risk will belowered; project quality can be better evaluated; construction cycle will be shortened; capital usage
efficiency will be raised;

2.

Laboratory designers:
Laboratory designers will understand the principles and methods of laboratory design, and will
have standards to follow and verify by, make fewer design faults and ensure laboratory design tobe more scientific and professional; laboratory environmental facility will be improved in terms ofsafety, energy conservation, environmental friendliness, as well as impacts on human health andwell-being.

3.

Laboratory constructors:
Laboratory constructors will have construction and acceptance standards to refer to; theconstruction quality will be raised; technology advancement will be promoted; the industry will befurther regulated.

4.

Laboratory users:
Laboratory users will understand the principles and methods of laboratory design; stakeholders
can communicate with each other in a more informed way and evaluate laboratories based oncommon standards, making laboratory use, operation and management more scientific andregulated. Smart laboratories will allow more functions and add value by integrating technologies
of big data, cloud computing and internet of things, etc.

5.

Laboratory operators:
Laboratory operators will understand the principles and methods of laboratory design, which will
facilitate the maintenance of laboratories; Smart laboratories will enable the remote digital controlof laboratory operation and facilitate reliable, efficient and convenient maintenance.

6.

Society:
The society will be able to cultivate more professional personnel in the field of laboratory design; amore sound and fair development of laboratory design and construction both home and abroad will
be facilitated; more energy-saving and environmental-friendly design will promote the sustainable
development of the society; the premium laboratories will inspire the creativity of researchers andpromote the advancement and development of technologies. Smart laboratories will facilitate
technological progress, product quality improvement, data recognition as well as international
trade.

V01/2019

Form 1: Proposal for a new field of technical activity
Page 7

An expression of commitment from the proposer to provide the committee secretariat if
the proposal succeeds.
If the proposal is accepted, China is willing to undertake the work of secretariat of the new TC and will
provide all necessary resources including financial and human resources as well as facility supports.
A partnership agreement between China and France at committee level is foreseen.

V01/2019

Form 1: Proposal for a new field of technical activity
Page 8

Purpose and justification for the proposal. (The purpose and justification for the creationof a new technical committee shall be made clear and the need for standardization in thisfieldshall be justified. Clause C.4.13.3 of Annex C of the ISO/IEC Directives, Part 1
contains a menu of suggestions or ideas for possible documentation to support andpurpose and justification of proposals. Proposers should consider these suggestions,but they are not limited to them, nor are they required to comply strictly with them. Whatis most important is that proposers develop and provide purpose and justification
information that is most relevant to their proposals and that makes a substantial businesscase for the market relevance and the need for their proposals. Thorough, well-developed
and robust purpose and justification documentation will lead to more informed
consideration of proposals and ultimately their possible success in the ISO IEC system.)
The rationale for setting up laboratory design TC is as follows:
1. Laboratories serve as the foundation for technological progress and product quality assurance andplay a pivotal role in social and economic development. Worldwide, the laboratory construction
volume is rising year by year, with trillions of USD invested into construction of new laboratories andrenovation of existent ones. However, on a global scale there is no standard on design of various
types of laboratories that project owners, designers, users and quality supervision authorities canrefer to, resulting in a number of problems in laboratory construction worldwide;
2. Lack of systematic laboratory design standards is the fundamental cause of frequent occurrence oflaboratory accidents impacting laboratory safety and occupants’ health, some of which may also
seriously jeopardize public health (such as BSL – 3 and BSL - 4 laboratories);
3. Currently there are no internationally agreed systematic standards on laboratory design andconstruction. The existing ISO laboratory quality management standard (ISO/IEC 17025:2017(Section 6.3: Facilities and environmental conditions) recognizes that robust and quality outputs
from laboratories are dependent on their facilities and environmental conditions but does not provide
any guidance on laboratory design.
4. In recent years, there is an increasing demand from Chinese market for various types oflaboratories, with hundreds billions of Chinese RMB invested each year in laboratory construction.
In the process, the standards system of laboratory design and construction in China have been
gradually established. Now China has not only developed laboratory design standards, but also
laboratory construction and acceptance standards, with the corresponding standards for laboratoryenvironmental facilities being established along the way. China’s laboratory design standards
system not only covers the general planning of laboratory, experiment procedure, layout, electricaland water supply, drainage, heating, ventilation and air purification, furniture, fire prevention, safety,
energy efficiency and environmental protection. During the standards compilation, experts andscholars integrated new technologies, materials and processes proven technically and economicallyeffective in practice into the standards, which has greatly improved the level of laboratory
construction in China, and provided support to the economic and social development. By setting up
the laboratory design TC, China is willing to harness its accumulated experience and work together
with other ISO member countries on the development of ISO laboratory design standard, in order tobenefit other countries around the world;
5. It has been shown in many cases that, as a result of unhealthy laboratory of environment, theresearchers working in laboratories developed diseases such as lung cancer, leukemia and brain
cancer. The underlying causes of these problems are the lack of laboratory design standards on
health.
6. Environmental protection, energy efficiency and emissions reduction in laboratory construction will
be given more prominence, addressing climate change issues and meeting sustainable
development goals.
7. Lack of standards on Smart laboratories that integrate facilities and instrumentation has adversely
impacted the generation and utilization of quality laboratory data.
The establishment of laboratory design TC will:

V01/2019

Form 1: Proposal for a new field of technical activity
Page 9

1. promote the development and implementation of international standards on laboratory design;
2. provide standards for the design of various types of laboratories and allow laboratory designprinciples and methods to be known on a global scale in order to avoid the occurrence of accidents
impacting safety and health;
3. provide professional references for ensuring scientific laboratory facilities and environmental
conditions, and technical support to guarantee the data reliability of research and testinglaboratories;
4. provide technical requirements on laboratory environment conditions in order to minimize theadverse impact on the health of laboratory personnel;
5. provide technical requirements on environment protection in order to promote energy saving andemission reduction;
6. provide technical requirements on the intelligent data retrieval and processing, in order to facilitate
global data sharing;
7. provide technical requirements on data traceability, in order to ensure the truthfulness of data, andthus facilitate the R&D innovation and improvement of product quality;
8. provide technical requirements on smart laboratory, in order to the facilitate the mutual data
recognition among laboratories, promote the technological progress and development ofinternational trade.

Signature of the proposer
SAC

Further information to assist with understanding the requirements for the items above can befound in the Directives, Part 1, Annex C.

V01/2019

ANNEX 1
Planning principles / laws, standards and regulations from various countries:
Australia / New Zealand
1. AS/NZS 2982:2010 Laboratory design and construction
2. AS/NZ 2243 Safety in Laboratories Series:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.

AS/NZ 2243.1:2005 Planning and Operational Aspects
AS/NZ 2243.2:2006 Chemical Aspects
AS/NZ 2243.3:2010 Microbiological safety and containment
AS/NZS 2243.4:2018 Safety in laboratories - Ionizing radiations
AS/NZ 2243.5:2004 Non-ionizing radiations – Electromagnetic, sound andultrasound
AS/NZ 2243.6:2010 Plant and equipment aspects
AS/NZ 2243.7:1991 Electrical aspects
AS/NZ 2243.8:2014 Fume cupboards
AS/NZ 2243.9:2009 Recirculating fume cabinets
AS/NZ 2243.10:2004 Storage of chemicals

Switzerland
1. Labor Law (ArG), its regulations and the guidelines
2. "Law on the safety of technical equipment and devices" (STEG)
3. "Regulation on the safety of technical equipment and devices" (STEV)
4. "Ordinance on the protection of workers against endangerment by micro-organisms"(SAMV)
5. Inclusion Ordinance (ESV) No. 814.912, Ordinance on the Handling of Organisms
in Closed Systems
6. Ordinance on the handling of organisms in the environment (release ordinance, FrSV)
7. Radiation Protection Ordinance No. 814.554, Ordinance on the handling of open
radioactive radiation sources
Federal Coordination Commission for Occupational Safety (EKAS)
1. EKAS - Guideline No. 1871 Chemical laboratories
2. EKAS - Guideline No. 6501 acids and alkalis
3. EKAS - Guideline No. 1825 Flammable liquids
4. EKAS Guideline No. 6508 Involvement of occupational physicians and otheroccupational safety specialists
5. EKAS - Guideline No. 6512 Work equipment
6. EKAS 6807 Checklist: Maintenance of ventilation and air conditioning systems(RLT systems)
7. SUVA - Directive "Explosion Protection - Principles, Minimum Requirements,

Zones"8. SUVA- Fact sheet No. 33038 "Internal transport of easily combustible liquids"
9. SUVA - Guideline no. 1864.d Guidelines for cold rooms and freezers
10. SUVA 67001 Traffic routes for persons
11. SUVA 67009 Noise at work
12. SUVA 67012 floors
13. SUVA 67013 Handling of solvents
14. SUVA 67032 Storage shelves and drawer cabinets
15. SUVA 67045 Cleaning and maintenance of buildings
16. SUVA 67054 Compressed air
17. SUVA 67068 Gas cylinders
18. SUVA 67070 Vibrations at work
19. SUVA 67071 Storage of easily combustible liquids
20. SUVA 67072 Doors and gates
21. SUVA 67083 Static electricity. Explosion risks when handling flammable liquids
22. SUVA 67084 Acids and alkalis
23. SUVA 67089 Load transport by hand
24. SUVA 67091 Personal Protective Equipment
25. SUVA 67132 Explosion risks (Explosion protection document for SMEs)
26. SUVA 67142 storage and stacking
27. SUVA 67149 Dealing with microorganisms
28. SUVA 67157 Escape routes
29. SUVA 67171 Technical noise protection measures
30. SUVA 67189 Stop the tripping and falling accidents when cleaning buildings
31. SUVA 84040 Eight vital rules for the maintenance of machinery and equipment
32. SUVA 84042 5 + 5 vital rules in dealing with electricity
33. SUVA Limits at the workplace
34. SUVA 86048 Acoustic limit and guide values
EN standards
1. EN 12128 "Biotechnology - Laboratories for research, development and analysis –Containment levels of microbiological laboratories, areas of risk, localities and physicalsafety requirements".
2. EN 14056 "Laboratory furniture - Recommendations for design and installation"
3. EN 14175 "Fume cupboards " (part 1 to 7)
4. EN 13150 Workbenches for laboratories - Dimensions, safety requirements and test
methods
5. EN 13792 Colour coding of taps and valves for use in laboratories
6. EN 14470 Fire safety storage cabinets (part 1 and 2)
7. EN 312 Particleboards - Specifications
8. EN 15154 Emergency safety showers (part 1 to 4)
9. EN ISO 14644 Cleanrooms and associated controlled environments (part 1 to 15)

France
1. NF X 15-206 " Laboratory fume cupboards - Threshold for confinement test"
2. NF X 15-211 " Laboratory equipment - Recirculatory filtration fume cupboard General, classification, requirements"
3. NF X 15-221 " Emergency safety showers - Permanently plumbed-in body showers
for sites other than laboratories"
Germany
1. DIN 12980 Laboratory installations - Safety cabinets and glove boxes for cytotoxic
substances and other CMR drugs "China
1. GB50346 Biosafety Laboratory Building Specification
2. GB19489 Laboratory - General Requirements for Biosafety
3. GB/T27476.1 Safety of Testing Laboratory
4. JGJ 91-93 Design code for scientific experiment buildings.
5.GB/T 32146.1-2015 Technical requirements of design and construction for inspection
and testing laboratory- Part 1: general specification
6.GB/T 32146.2-2015 Technical requirements of design and construction for inspection
and testing laboratory- Part 2: Electrical laboratory
7.GB/T 32146.3-2015 Technical requirements of design and construction for inspection
and testing laboratory- Part 3: Food laboratory
8.GB/T 37140-2018 Technical requirements acceptance specification for inspection
and testing laboratory