BIS vs CE Certification for Plastic Injection Molding
Machinery
Focus on Functional Safety with Hazard Analysis
Grok 3
May 22, 2025
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Overview
Objective: Compare BIS Regulation (Omnibus Technical Regulation, 2024) and
CE Certification (Machinery Directive 2006/42/EC) for plastic injection molding
machinery (HS Code 8477).
Focus: Functional safety, 35 hazards with PL requirements, protective measures,
components, and real-life scenario.
Standards: BIS (IS/ISO 20430:2020, IS 16810:2018) vs CE (EN ISO 20430:2020, EN
ISO 13849-1:2015).
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
BIS Regulation
Source: Machinery and Electrical Equipment Safety Order, 2024.
Scope: HS Code 8477 for domestic use in India, excludes exports.
Standards:
Type A: IS 16819:2018/ISO 12100:2010.
Type B: IS 16810:2018/ISO 13849-1:2015, IS 16501:2017/IEC 62061:2005.
Type C: IS/ISO 20430:2020.
Certification: Mandatory BIS license, Standard Mark, technical file.
Enforcement: BIS surveillance, penalties under BIS Act.
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
CE Certification
Source: Machinery Directive 2006/42/EC.
Scope: Machinery in EEA market.
Standards:
Type A: EN ISO 12100:2010.
Type B: EN ISO 13849-1:2015, EN 62061:2021.
Type C: EN ISO 20430:2020.
Certification: Self-declaration, CE mark, technical file; Notified Body for
high-risk.
Enforcement: EEA member state surveillance, varying penalties.
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Key Differences in Functional Safety
Certification: BIS requires third-party BIS certification; CE allows
self-certification (Notified Body for Annex IV).
Standards: BIS uses older IEC 62061:2005; CE uses EN 62061:2021.
Labeling: BIS mandates Standard Mark; CE requires CE mark.
Enforcement: BIS centralized; CE decentralized.
Market: BIS for India; CE for EEA.
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Hazards Overview
Categories: Mechanical, Thermal, Electrical, Hydraulic, Pneumatic, Ergonomic,
Chemical, Fire, Maintenance, Human Error.
Total Hazards: 35, each with PL requirement, protective measures, and
components.
PL Calculation: Based on Severity (S), Frequency (F), Possibility of Avoidance (P)
per ISO 13849-1:2015.
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Hazard Analysis (1-10)
Hazard Description PL Measure Components
Crushing Mold closing PLd Interlocking SICK i10 Lock, Banner
(Mold) crushes limbs guards, two- STB
hand control
Shearing Platens shear PLc Fixed guards, Keyence GL-R, Steel
(Platens) body parts light curtains guard
Entanglement Screw entangles PLc Fixed guards, in- Omron D4SL-N, Steel
(Screw) clothing terlocks guard
Ejector Pin Pins strike opera- PLb Fixed guards, Steel guard, Labels
Impact tors signs
Pinch Points Tie bars pinch fin- PLb Guarding, sen- Omron D4SL-N, Prox-
(Tie Bars) gers sors imity sensor
Falling Mold Mold handling PLc Safety locks, SICK i10 Lock, Me-
Parts causes falls stops chanical stop
Conveyor Conveyors en- PLc Guards, e-stop Keyence GL-R, Schnei-
Entangle- tangle limbs der XB5
ment
Clamp Move- Uncontrolled PLd Interlocking Siemens 3SK, SICK i10
ment clamp motion guards, PLC Lock
Tool Change Tool change im- PLb Safety locks, Omron D4SL-N, La-
Injury pacts signs bels
Material Heavy parts PLc Safety cranes, Konecranes, Load cell
Handling crush sensors
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Hazard Analysis (11-20)
Hazard Description PL Measure Components
Barrel Burns Barrel >200°C PLb Insulation, signs Nomex covers, Labels
burns
Plastic Molten plastic PLc Shields, PPE Polycarbonate shield,
Splash splashes PPE signage
Nozzle Con- Nozzle burns PLb Insulation, gates Ceramic covers, Om-
tact ron D4SL-N
Heater Fail- Overheating PLc Temp sensors, IFM TA, Pilz PNOZ X
ure heaters relays
Mold Over- Excessive mold PLb Temp monitor- Omega TC, Werma
heating temp ing, alarms alarm
Electric Exposed wiring PLc Insulated panels, Schneider NSX MCCB
Shock breakers
Unexpected Control failure PLd E-stop, relays Schneider XB5,
Start-Up Siemens 3SK
Short Circuit Fire from faults PLc Circuit protec- Eaton fuses, Apollo
tion, fire detec- detector
tion
Static Dis- Static buildup PLb Grounding, ESD StaticTech kit
charge mats
Panel Access Unauthorized cir- PLc Interlocked pan- SICK i10 Lock
cuit access els
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Hazard Analysis (21-30)
Hazard Description PL Measure Components
Fluid Injec- Hydraulic line PLc Safety valves, Bosch Rexroth DBDS,
tion rupture sensors IFM PN
Cylinder Fail- Uncontrolled PLd Safety valves, Parker valve, Siemens
ure cylinder controls 3SK
Hose Burst Hose failure PLc Reinforced Gates hose, Bosch
hoses, relief valve
Pump Fail- Overpressure PLc Sensors, shutoff IFM PN, Eaton valve
ure
Air Pressure Sudden release PLb Relief valves, Festo VUVG valve
Release injury mufflers
Actuator Uncontrolled ac- PLc Safety valves, SMC SY, Balluff sensor
Failure tuator sensors
Repetitive Manual loading PLb Automation, er- UR5e arm, Ergonomic
Strain gonomic design grips
Noise Expo- Noise >85 dB PLb Enclosures, Soundproof panels,
sure alarms Werma
Vibration Ex- Prolonged vibra- PLb Dampers, PPE Rubber mounts,
posure tion Gloves
Poor Visibil- Inadequate light- PLb LED lighting, Philips LED, Labels
ity ing signs
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Hazard Analysis (31-35)
Hazard Description PL Measure Components
Fumes Toxic fumes from PLc Ventilation, de- Camfil purifier,
plastic tectors Dräger X-am
Material Resin spills caus- PLb Containment SpillTech tray, Labels
Spillage ing slips trays, signs
Fire from Component igni- PLc Fire detection, Apollo detector, Ansul
Overheating tion suppression system
LOTO Failure Maintenance PLd LOTO systems, Brady LOTO kit, SICK
without isolation interlocks i10 Lock
Incorrect Operator errors PLd Training, two- Banner STB, Training
Operation hand controls program
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Meeting PL Requirements
PLd (High Risk):
Category 3/4, MTTFd > 30 years, DCavg > 90%.
Example: SICK i10 Lock interlocks with Siemens 3SK PLC for mold crushing.
PLc (Moderate Risk):
Category 2/3, MTTFd > 10 years, DCavg > 60%.
Example: Keyence GL-R light curtains for shearing.
PLb (Low Risk):
Category 1, MTTFd > 10 years.
Example: Nomex insulation for barrel burns.
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Practical Example: 300-Ton Machine
Machine: 300-ton injection molding machine for automotive parts.
BIS Compliance:
Interlocks (SICK i10 Lock, PLd), E-stops (Schneider XB5, PLd).
Hydraulic valves (Bosch Rexroth, PLc).
Comply with IS/ISO 20430:2020, BIS license.
CE Compliance:
Risk assessment per EN ISO 12100:2010.
Same components, Declaration of Conformity, CE mark.
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Real-Life Scenario
Context: Pune manufacturer for India and EEA.
Challenges:
BIS: Certification delays, labeling costs.
CE: Technical file complexity, Notified Body costs.
Solution: Use ISO 20430:2020, dual-certified components (SICK, Schneider).
Outcome: Streamlined compliance, cost efficiency.
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
Conclusion
Similarities: Aligned standards (ISO 20430, ISO 13849-1).
Differences: BIS mandates third-party certification; CE allows self-certification.
Recommendation: Standardize on dual-certified components, align with ISO
20430.
Grok 3 BIS vs CE Certification for Plastic Injection Molding Machinery
